-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, SV4bm1VEpT4CAA6eN26cM7KQaUsUzPodzm8B3sjQcCo11OzOqfy0is3X35fKRZbD P/EXaV+CXXMi9dTRQTH8aQ== 0001437749-10-003602.txt : 20101029 0001437749-10-003602.hdr.sgml : 20101029 20101029171018 ACCESSION NUMBER: 0001437749-10-003602 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20100731 FILED AS OF DATE: 20101029 DATE AS OF CHANGE: 20101029 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Tamir Biotechnology, Inc. CENTRAL INDEX KEY: 0000708717 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 222369085 STATE OF INCORPORATION: DE FISCAL YEAR END: 0731 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-11088 FILM NUMBER: 101152676 BUSINESS ADDRESS: STREET 1: 300 ATRIUM DRIVE CITY: SOMERSET STATE: NJ ZIP: 08873 BUSINESS PHONE: 732-652-4525 MAIL ADDRESS: STREET 1: 300 ATRIUM DRIVE CITY: SOMERSET STATE: NJ ZIP: 08873 FORMER COMPANY: FORMER CONFORMED NAME: ALFACELL CORP DATE OF NAME CHANGE: 19920703 10-K 1 tamir_10k-073110.htm ANNUAL REPORT tamir_10k-073110.htm


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
______________________________________________
 
FORM 10-K

x
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended July 31, 2010

o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from __________ to __________

0-11088
Commission file number

TAMIR BIOTECHNOLGY, INC.
(Exact name of registrant as specified in its charter)

Delaware
22-2369085
(State or other jurisdiction of
(I.R.S. Employer
incorporation or organization)
Identification No.)

11 Deer Park Drive, Suite 204, Princeton Corporate Plaza, Monmouth Junction, NJ
(Address of principal executive offices)
08852
(Zip Code)

Registrant’s telephone number, including area code:  (732) 652-4525
 
Securities registered pursuant to Section 12(b) of the Act:
None

Securities registered pursuant to Section 12(g) of the Act:
None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.  Yes o     No x

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.  Yes o     No x

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x     No o

 
 

 
 
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes o     No o

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company.  See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.  (Check one):     Large Accelerated Filer o       Accelerated Filer o       Non-accelerated Filer o       Smaller Reporting Company x

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)   Yes o     No x

The aggregate market value of the voting and non-voting common equity held by non-affiliates based upon the reported last sale price of the common stock on January 31, 2010, the end of the registrant’s second fiscal quarter, was approximately $7,519,000.  As of October 25, 2010 there were 47,323,880 shares of common stock, par value $.001 per share, outstanding.

Documents Incorporated by Reference
 
None

 
 

 

TABLE OF CONTENTS
 
PART I
 
Page
       
 
ITEM  1.
Business
5
       
 
ITEM  2.
Properties 17
       
 
ITEM  3.
Legal Proceedings 17
       
 
ITEM  4.
Reserved
18
       
PART II
   
       
 
ITEM  5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 18
       
 
ITEM  7.
Management's Discussion and Analysis of Financial Condition and Results of Operations 20
       
 
ITEM  7A.
Quantitative and Qualitative Disclosures About Market Risk
27
       
 
ITEM  8.
Financial Statements and Supplementary Data 27
       
 
ITEM  9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 27
       
 
ITEM 9A.
Controls and Procedures
28
       
  ITEM 9B.
Other Information
29
       
PART III
   
       
 
ITEM 10.
Directors, Executive Officers and Corporate Governance
29
       
 
ITEM 11.
Executive Compensation
34
       
 
ITEM 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
46
       
 
ITEM 13.
Certain Relationships and Related Transactions and Director Independence
48
       
 
ITEM 14.
Principal Accounting Fees and Services
49
       
PART IV
   
       
 
ITEM 15.
Exhibits and Financial Statement Schedules
50

 
3

 

The following trademarks appear in this annual report on Form 10-K: ONCONASE® is the registered trademark of Tamir Biotechnology, Inc., exclusively for its anti-cancer agent, Alimtaâ is the registered trademark of Eli Lilly, Zolinzaâ is the registered trademark of Merck & Co., Avastin® is the registered trademark of Genentech and Ganciclovir® is a registered trademark of Roche.

This annual report on Form 10-K includes forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  We have based these forward looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business.  These forward looking statements are subject to a number of risks, uncertainties, and assumptions about us, including, among other things:

·  
the failure to obtain regulatory approval of our lead product;
·  
the failure to achieve positive results in clinical trials;
·  
competitive factors;
·  
available financial resources and the ability to secure adequate funding for development projects;
·  
the ability to attract and retain qualified management;
·  
relationships with pharmaceutical and biotechnology companies;
·  
the ability to develop safe and efficacious drugs;
·  
variability of royalty, license, and other revenue;
·  
the failure to satisfy the performance obligations in our agreements;
·  
the ability to enter into future collaborative agreements;
·  
uncertainty regarding our patents and patent rights (including the risk that we may be forced to engage in costly litigation to protect such patent rights and the material harm to us if there were an unfavorable outcome of any such litigation);
·  
governmental regulation;
·  
technological change;
·  
changes in industry practices;
·  
the ability of our senior secured creditors to realize their security interest in all of our assets and to demand repayment of amounts owed to such creditors;
·  
certain limitations on our ability to use a portion of the proceeds from our October 2009 private financing;
·  
uncertainty regarding the outcome of legal proceeding including the risk that we may be forced to engage in lengthy, time-consuming and expensive litigation and the material adverse effect to us of any unfavorable outcome of any such litigation;
·  
one-time events.
 
In addition, in this annual report on Form 10-K, the words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and similar expressions, as they relate to us, our business, or our management, are intended to identify forward looking statements. All of our forward looking statements are qualified in their entirety by reference to the factors discussed in this annual report under the heading ITEM 1A.—RISK FACTORS, and any documents incorporated by reference that describe risks and factors that could cause results to differ materially from those projected in these forward looking statements.

We caution you that the risk factors contained herein are not exhaustive.  We operate in a continually changing business climate which can be expected to impact our forward looking statements, whether as a result of new information, future events, or otherwise, after the date of this annual report. In light of these risks and uncertainties, the forward looking events and circumstances discussed in this annual report may not occur and actual results could differ materially from those anticipated or implied in the forward looking statements.  Accordingly, you should not rely on forward looking statements as a prediction of actual results.

All information in this annual report is as of October 29, 2010, unless otherwise noted and we undertake no obligation to update this information.
 
 
4

 

PART I

ITEM 1.  BUSINESS.

BUSINESS OVERVIEW

Tamir Biotechnology, Inc. (formerly known as Alfacell Corporation) is a Delaware corporation incorporated on August 24, 1981.  We are a biopharmaceutical company primarily engaged in the discovery and development of a new class of therapeutic drugs for the treatment of cancer and other pathological conditions.  Our proprietary drug discovery and development program consists of novel therapeutics which are being developed from amphibian ribonucleases (RNases).

RNases are biologically active enzymes that split RNA molecules.  RNases are enzymes which play important roles in nature, including the embryonic development of an organism and regulation of various cell functions.  RNA is an essential bio-chemical cellular component necessary to support life.  There are various types of RNA, all of which have specific functions in a living cell.  They help control several essential biological activities, namely; regulation of cell proliferation, maturation, differentiation and cell death.  Therefore, they are believed to be good candidates for the development of therapeutics for cancer and other life-threatening diseases, including HIV and autoimmune diseases, that require anti-proliferative and apoptotic, or programmed cell death, properties.

ONCONASE® (ranpirnase) is a novel amphibian ribonuclease, unique among the superfamily of pancreatic ribonuclease, isolated from the eggs of the Rana pipiens (the Northern Leopard frog).  Ranpirnase is the smallest known protein belonging to the superfamily of pancreatic ribonuclease and has been shown, on a molecular level, to re-regulate the unregulated growth and proliferation of cancer cells.  Unlike most anti-cancer agents that attack all cells regardless of phenotype (malignant versus normal) and cause severe toxicities, ONCONASE® is not an indiscriminate cytotoxic drug (cell killing agent).  ONCONASE® primarily affects exponentially growing malignant cells, with activity controlled through unique and specific molecular mechanisms.

The molecular mechanisms which determine the apoptotic cell death induced by ranpirnase have been identified.  tRNA (transfer RNA), rRNA (ribosomal RNA), mRNA (messenger RNA) and miRNA (micro RNA) are all different types of RNA with specific functions in a living cell.  Ranpirnase preferentially degrades tRNA and targets miRNA, leaving rRNA and mRNA apparently undamaged.  The RNA damage induced by ranpirnase appears to represent a “death signal”, or triggers a chain of molecular events culminating in the activation of proteolytic enzyme cascades which, in turn, induces disintegration of the cellular components and finally leads to cell death.  It has been shown that there is a protein synthesis inhibition-independent component, which, together with the changes indu ced by the protein synthesis inhibition, results in tumor cell death.

ONCONASE®, our lead drug product candidate, has been evaluated in human clinical trials for the treatment of various forms of cancer.  Our most recent clinical trial for ONCONASE® was a confirmatory Phase IIIb registration trial that was designed to evaluate the efficacy, safety and tolerability of the combination of ONCONASE® and doxorubicin as compared to doxorubicin alone in the treatment of patients with unresectable (inoperable) malignant mesothelioma (“UMM”), a rare and deadly form of lung cancer.  Enrollment in the Phase IIIb tria l was completed in September 2007.  In May 2008, we reported that the preliminary statistical analysis of data from our ONCONASE® confirmatory Phase IIIb clinical trial did not meet statistical significance for the primary endpoint of survival in UMM.  However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen, a predefined primary data set for this sub-group of patients in the trial, which represents a currently unmet medical need.  The Food and Drug Administration or the FDA, recommended that an additional clinical trial be conducted in UMM patients that have failed one prior chemotherapy regimen, prior to filing a New Drug Application or NDA.  At this time we intend to explore opportunities involving further clinical trials for ONCONASE® for the UMM indication as a second line therapy.  Other indications are being pursued, including lung cancer and other solid tumors and currently, we expect to use the proceeds we received from the private financing we closed in October 2009 to initiate a Phase II clinical trial of ONCONASE® for the treatment of non-small cell lung cancer in patients who have reached maximum progression after receiving two cycles of Alimta in combination with carboplatinum.  We anticipate enrolling the first patient for this trial in late 2010.

 
5

 
 
We believe that ONCONASE®, as well as another group of our amphibian RNases known as Amphinases, may also have applications in a variety of other areas in addition to those being investigated currently in our clinical development program.  Amphinase is currently in the pre-clinical research and development stage.

We are a development stage company as defined in the Accounting Standards Codification (“ASC”) Topic “Development Stage Entities”.  We are devoting substantially all of our present efforts to establishing a new business and developing new drug products. Our planned principal operations of marketing and/or licensing new drugs have not commenced and, accordingly, we have not derived any significant revenue from these operations.

MARKET OVERVIEW

According to the American Cancer Society (“ACS”) 2009 Cancer Facts and Figures, cancer is the second leading cause of death in the United States, accounting for one in every four deaths.  The ACS 2009 Cancer Facts and Figures also estimates that doctors will diagnose over 1.5 million new cases of cancer in the United States in 2009.  The National Institutes of Health or NIH estimate that the annual cost of cancer in 2008 was approximately $228.1 billion, including $93.2 billion in direct medical costs and $18.8 billion for morbidity costs, which includes the cost of lost productivity.

Cancer is characterized by uncontrolled cell division resulting in the growth of a mass of cells commonly known as a tumor.  Cancerous tumors can arise in almost any tissue or organ and cancer cells, if not eradicated, spread, or metastasize, throughout the body.  Cancer is believed to occur as a result of a number of factors, including hereditary and environmental factors.

For the most part, cancer treatment depends on the type of cancer and the stage of disease progression. Generally, staging is based on the size of the tumor and whether the cancer has metastasized or spread.  Following diagnosis, solid tumors are typically surgically removed or the patient is given radiation therapy.  Chemotherapy is the principal treatment for tumors that are likely to, or have, metastasized.  Chemotherapy involves the administration of drugs which are designed to kill cancer cells, affect the growth of tumors, or reduce bloodflow to tumors, in an effort to reduce or eliminate cancerous tumors.

Because in most cases cancer is fatal, cancer specialists attempt to attack the cancer aggressively, with as many therapies as available and with as high a dose as the patient can tolerate.  Since traditional chemotherapy attacks both normal and cancerous cells, treatment often tends to result in complicating side effects.  Additionally, cells which have been exposed to several rounds of chemotherapy develop a resistance to the cancer drugs that are being administered.  This is known as “multi-drug resistance.”  The side effects of chemotherapy often limit the effectiveness of treatment.  Cancers often recur and mortality rates remain high.  Despite large sums of money spent on cancer research, current treatments are largely inadequate and impro ved anti-cancer agents are needed.

We believe that the products we currently have under development could be used to target a broad range of solid tumors.  The table below shows the incidence and mortality estimated for the year 2009 for various types of solid tumor cancers that our products could be designed to treat:

Cancer Indication
 
New Cases
 
Deaths
Lung
 
219,440
 
159,390
Breast
 
194,280
 
40,610
Brain
 
22,070
 
12,920
Esophageal
 
16,470
 
14,530
         
Source: National Cancer Institute        
 
 
6

 

Competition

There are many companies with resources significantly greater than ours that are currently marketing approved drug products that treat, and are developing new drug products that are designed to treat, several of the cancers and viruses that we may seek to treat with our products. The drug products currently marketed or developed by these companies may prove to be more effective that the products we seek to develop.
 
We are not aware, however, of any product currently being marketed that has the same mechanism of action as our proposed anti-tumor agent, ONCONASE®.  Search of scientific literature reveals no published information that would indicate that others are currently employing this method or producing such an anti-tumor agent.  However, we cannot assure you that others may not develop new treatments that are more effective than ONCONASE®.

BUSINESS STRATEGY

Our goal is to become a leading biopharmaceutical company focused on discovering and developing innovative anti-cancer and anti-viral treatments based on our proprietary RNase technology platform.  Our strategy consists of the following key elements:

Focus on the growing cancer market

Cancer is the second leading cause of death in the United States, yet there remain unmet needs, and current treatments remain ineffective and inadequate for some populations.  Given the life-threatening nature of cancer, the FDA has adopted procedures to accelerate the approval of cancer drugs.  We intend to continue to use our expertise in the field of cancer research to target this significant market opportunity for cancer drug development.

In December 2009, we sent four of our compounds (ONCONASE®, P31, rAmphinase 2, natural Amphinase 3) to the National Cancer Institute (NCI) for their sixty cell line screening study.  In February 2010, the results of the one dose screening study performed at NCI resulted in positive anti-cancer activity across several different cancer cell lines tested.  Due to the one dose positive results, NCI recommended further screening of our compounds at five different dose levels.  In June 2010, NCI reported the results of the sixty cell line screening at five different dose levels.  These results were quite positive, and our compounds were recommended for further pre-clinical and clinical evaluation. 60; We have initiated discussions with NCI and are currently seeking support for further pre-clinical and clinical development of our compounds.

Focus on the growing anti-viral market

In November 2009, we entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID) to screen our compounds (ONCONASE®, P31, rAmphinase 2) for its potential anti-viral activity. In July 2010, scientists supported by NIAID reported positive in vitro results after testing our compounds for Dengue fever and Yellow fever.  According to the scientists supported by NIAID, these results have rarely been seen before. Currently there is no therapy available to treat Dengue and Yellow fever post-infection.  Further in vitro studies for Severe Acute Respiratory Syndrome (SARS) vi rus, and Cytomegalovirus (CMV), have also yielded positive results.  In the case of CMV, a virus that is a member of the herpesvirus family, our compounds were compared to Ganciclovir, a drug marketed by Roche.  Results confirmed that two of our compounds were between three and eleven times more potent than Ganciclovir in a head-to-head comparison. Moreover, our compounds did not display the level of toxicity inherent with any of the drugs approved by the FDA for CMV disease.  None of the approved drugs for this indication are well tolerated by patients.  In 2008, the market for CMV drugs was $600 million with Ganciclovir controlling over 90% of the market.  Industry observers estimate that sales for CMV disease would top one billion dollars if there were a drug available that was both safe and effective.  Based upon the results of the in vitro studies conducted to date, we anticipate starting in vivo studies sometime in the first quarter of 2011.  Subject to the availability of funding, further testing on other viruses is currently on-going.
 
 
7

 

Develop our existing product portfolio

We currently have a portfolio of clinical and pre-clinical drug product candidates under development for potential use as anti-cancer, anti-viral, and other therapeutics.  We intend to further develop these drug product candidates both by utilizing our internal resources and by continuing to collaborate with other companies and leading governmental and academic research institutions.
 
Commercialize pharmaceutical products focused on cancer in selected markets
 
Our current strategy is to partner with third parties to market our future products to oncologists, virologists, and other key specialists involved in the treatment of cancer and viruses.  We may also elect to develop an appropriately-sized internal oncology sales and marketing capability in the United States.  This group may function as a standalone operation or in a supportive, co-promotion capacity in collaboration with a partner. 
 
RESEARCH AND DEVELOPMENT PROGRAM
 
Research and development expenses for the fiscal years ended July 31, 2010 and 2009 were approximately $517,000 and $3,268,000, respectively.  Our research and development programs focus primarily on the clinical and pre-clinical research and development of therapeutics from our pipeline of amphibian RNases.

Clinical Development Program

ONCONASE® was most recently evaluated as a treatment for UMM in an international, centrally randomized, confirmatory Phase IIIb registration trial.  Malignant mesothelioma is a rare cancer, primarily affecting the pleura (lining of the lungs), and is usually associated with asbestos exposure.  The first Phase III trial of ONCONASE® in UMM was completed in 2000. The most recent confirmatory Phase IIIb registration trial was closed to patient accrual in September 2007.

The confirmatory Phase IIIb registration trial was a randomized and controlled clinical trial designed to evaluate the efficacy, safety and tolerability of the combination of ONCONASE® and doxorubicin as compared to doxorubicin alone, and powered to reach a statistically significant difference in overall survival between the ONCONASE® + doxorubicin treatment group and the doxorubicin treatment group at 316 evaluable events.  Patients were stratified based on Cancer Adult Leukemia Group B (“CALGB”) Group (1 to 4) and histology and then assigned treatment using a centralized randomization plan.  The primary endpoint of th e trial was overall patient survival.  The following data sets were analyzed for efficacy as per the statistical analysis plan for this clinical trial:

 
·
All patients randomized who received at least one dose of study therapy (evaluable patients),
 
·
Previously treated patients,
 
·
All patients randomized,
 
·
All patients who completed 6 cycles of therapy per protocol, and
 
·
All patients with identical inclusion criteria as used in the Alimta submission.

In addition, secondary endpoints that were analyzed in accordance with the Phase IIIb clinical trial statistical analysis plan included:

 
·
Tumor response rates,
 
·
Progression free survival,
 
·
Patient assessment of symptoms associated with malignant mesothelioma,
 
·
Investigator assessment of malignant mesothelioma symptoms,
 
·
Narcotic pain medication usage,
 
·
Lung function, and
 
·
Performance status.
 
 
8

 
 
In May 2008, we reported that the results of the preliminary statistical analysis of data from our ONCONASE® confirmatory Phase IIIb clinical trial did not meet statistical significance for the primary endpoint of survival in UMM. However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen, one of the predefined primary sub-group data sets for patients in the trial, which represents a currently unmet medical need.  At the pre-NDA meeting with the FDA in January 2009, the FDA recommended that an additional clinical trial be conducted in UMM patients that have failed one prior chemotherapy regimen, prior to filing an NDA.
 
A Phase I/II program to evaluate a new dose and administration schedule of ONCONASE® was initiated in 2005 to attempt to take advantage of potentially increased efficacy with higher and more frequent doses of ONCONASE®.  The Phase I portion of this program is complete and currently, we are in the process of initiating a Phase II clinical trial in non-small cell lung cancer (NSCLC) for patients who have reached maximum progression after receiving two cycles of Alimta in combination with carboplatinum regimens before the end of 2010.

Pre-Clinical Research Program

Our drug discovery and pre-clinical research programs form the basis for the development of specific recombinant RNases for chemically linking drugs and other compounds such as monoclonal antibodies, growth factors, etc., as well as developing gene fusion products with the goal of targeting various molecular functions.  These programs provide for joint design and generation of new products with outside collaborators.  Through these collaborations, we may own these new products along with, or we may grant an exclusive license to, the collaborating partner(s).

The multiple effects of biological activity of ONCONASE®, as well as several of our other compounds has led to research in areas of cancer biology.  Two important areas associated with significant market opportunities are radiation therapy and control of tumor angiogenesis, or new tumor blood vessel formation.  Many types of cancers undergo radiation therapy at early stages of the disease; however, success of such treatment is often limited.  We believe any agent capable of enhancing tumor radiosensitivity has great market potential.  Moreover, since the growth of essentially all types of cancer is dependent on new blood vessel formation, any agent that has anti-angiogenic activity, we believe, is most desirable.

In September 2010, we rented a lab space for the purpose of isolating and purifying both natural and recombinant amphinases.  These compounds have never undergone full screening for their potential anti-cancer and anti-viral activities.  Additionally, we intend to conduct further research for conjugation of our proteins with other molecules which are known to play an important role required for targeted therapies.

Ranpirnase Conjugates and Fusion Proteins

The concept of targeting potent toxins as effector molecules to kill cancer or other specifically targeted cells has been extensively evaluated over the last two decades.  An immunotoxin is an antibody linked to a toxic molecule that is used to destroy specific cells.  Several immunotoxins containing bacterial and plant toxins or other biotoxins, have been evaluated in human clinical trials.  Efficacy has always been limited due to the high incidence of immunogenicity, or an immune response, and other intolerable toxicities, including death.  Conjugation of ranpirnase to targeting ligands, or binding to other molecules, appears to eliminate this safety problem in pre-clinical studies.

A Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute, or NCI, has produced RN321, a conjugate of ranpirnase with a monoclonal antibody, that has demonstrated activity against non-Hodgkin’s lymphoma in preclinical studies.  The relative benefit of killing targeted tumor cells versus non-targeted healthy cells, or the therapeutic index, is greater than 200,000-fold with this conjugate.  This CRADA has been concluded and data published.

We have also developed a variety of uniquely designed versions of ONCONASE® and amphinase conjugates.  These compounds target the EGF receptors and neo-vascularization (tumor blood vessel formation) which have potential clinical application in a broad spectrum of solid tumors.

 
9

 
 
Novel Amphibian Ribonucleases (Amphinases)

We have also discovered another series of proteins, collectively named amphinases that may have therapeutic uses.  These proteins are bioactive in that they have an effect on living cells and organisms and have both anti-cancer and anti-viral activity.  All of the proteins characterized to date are RNases.  Preclinical testing of the new candidates collectively called amphinases showed them to be similarly active to ranpirnase.  Their chemical structure makes them ideal candidates for genetic engineering of designer products.

In September 2010, we rented a lab space for the purpose of isolating and purifying both natural and recombinant amphinases.  These compounds have never undergone full screening for their potential anti-cancer and anti-viral activities.  Additionally, we intend to conduct further research for conjugation of our proteins with other molecules which are known to play an important role required for targeted therapies.

These compounds have undergone screening by the National Institute of Allergy and Infectious Diseases (NIAID) against various RNA viruses and by outside collaborators.  One of these compounds, AC-03-636 has been determined to be active in yellow fever, Hepatitis C and Dengue fever.  The same compound has been evaluated at Johns Hopkins University in a sustained time release formulation for the treatment of brain tumors, or gliomas.

Evaluation Of ONCONASE® As A Radiation Enhancer

The p53 gene is a tumor-suppressor gene, which means that if it malfunctions, tumors may be more likely to develop.  Published preclinical studies have demonstrated that ONCONASE® causes an increase in both tumor blood flow and in median tumor oxygen partial pressure, causing tumor cells to become less resistant to radiation therapy regardless of the presence or absence of the functional p53 tumor-suppressor gene.  In pre-clinical research at the University of Pennsylvania, ONCONASE®, when combined with radiation therapy, enhanced the radiation-sensitivity to treatment in NSCLC tumor cells without causing the common radiation-induc ed tissue damage to non-tumor cells.  ONCONASE® inhibited sub-lethal damage repair, or SLDR and potentially lethal damage repair, or  PLDR in these animal models.  We believe these findings further expand the profile of ONCONASE® in vivo activities and its potential clinical utility and market potential.

ONCONASE® As a Resistance-Overcoming and  Apoptosis-Enhancing Agent

The Fas (CD95) cell surface receptor (and its Fas ligand FasL) has been recognized as an important “death” receptor involved in the induction of the “extrinsic” pathway of apoptosis.  The apoptotic pathways have been the preferred target for new drug development in cancer, autoimmune, and other therapeutic areas.

The Thoracic Surgery Branch of the NCI confirmed the synergy between ranpirnase and soluble Fas ligand, or sFasL in inducing significant apoptosis in sFasL-resistant Fas+tumor cells.  These results provided rationale for using ONCONASE® as a potential treatment of FasL-resistant tumors and possibly other disorders such as the autoimmune lympho-proliferative syndrome (ALPS).

Evaluation Of ONCONASE® And Other Compounds As An Anti-Viral Agent

The ribonucleolytic activity was the basis for testing ONCONASE® as a potential anti-viral agent against HIV.  The NIH has performed an independent in vitro screen of ONCONASE® against the HIV virus type 1.  The results showed ONCONASE® to inhibit replication of HIV by up to 99.9% after a four-day incubation period at concentrations not toxic to uninfected cells.  In vitro findings by the NIH revealed that ONCONASE® significantly inhibited production of HIV in several persistently infected human cell lines, preferentially breaking down viral RNA while not affecting normal cellular ribosomal RNA and messenger RNAs, which are essential to cell function.

Moreover, the NIAID also screened ONCONASE® for anti-HIV activity.  ONCONASE® demonstrated highly significant anti-HIV activity in the monocyte/macrophage, or anti-viral, system.  Ranpirnase may inhibit viral replication at several points during the life cycle of HIV, including its early phases.  Ranpirnase may inhibit replication of all different HIV-1 subtypes.  These properties of ranpirnase are particularly relevant in view of the extremely high and exponentially increasing rate of mutations of HIV that occur during infection, and which are primari ly responsible for the development of resistance to several currently available anti-viral drugs.  At present, over 50% of clinical isolates of HIV are resistant to both reverse transcriptase, mechanisms which combat viral replication, and protease inhibitors drugs, a class of anti-viral drugs.  An additional 25%, while being sensitive to protease inhibitors, are resistant to reverse transcriptase inhibitor drugs.

 
10

 
 
In November 2009, we entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID) to screen three of our compounds (ONCONASE®, P31, rAmphinase 2) for their potential anti-viral activity.  In July 2010, scientists supported by NIAID reported positive in vitro results after testing our compounds for Dengue fever and Yellow fever.  According to the scientists supported by NIAID, these results have rarely been seen before.  Currently there is no therapy available to treat Dengue and Yellow fever post-infection. Further in vitro studies for Severe Acute Respirat ory Syndrome (SARS) virus, and Cytomegalovirus (CMV), have also yielded remarkable results.  In the case of CMV, a virus that is a member of the herpesvirus family, our compounds were compared to Ganciclovir, a drug marketed by Roche.  Results confirmed that two of our compounds were between three and eleven times more potent than Ganciclovir in a head-to-head comparison.  Moreover, our compounds did not display the level of toxicity inherent with any of the drugs approved by the FDA for CMV disease.  None of the approved drugs for this indication are well tolerated by patients.  In 2008, the market for CMV drugs was $600 million with Ganciclovir controlling over 90% of the market.  Industry observers estimate that sales for CMV disease would top one billion dollars if there were a drug available that was both safe and effective.  Due to these compelling results, we anticipate starting in v ivo studies sometime in the first quarter of 2011.  Further testing on other viruses is currently on-going.

COMMERCIAL RELATIONSHIPS

License Agreements
 
In January 2008, we entered into a U.S. License Agreement for ONCONASE® with Par Pharmaceutical, Inc. (“Par”).  Under the terms of the License Agreement, Strativa Pharmaceuticals (“Strativa”), the proprietary products division of Par, received exclusive marketing, sales and distribution rights to ONCONASE® for the treatment of cancer in the United States and its territories. We retained all rights and obligations for product manufacturing, clinical development and obtaining regulatory approvals, as well as all rights for those non-U.S. jurisdictions in which we have not currently granted any such rights or obligations to third parties. We received a cash payment of $5 million upon the signing of the License Agreement and were entitled to additional development and sales milestone payments and double-digit royalties on net sales of ONCONASE®.

On September 8, 2009, we entered into a Termination and Mutual Release Agreement (the “Termination Agreement”) with Par pursuant to which our License Agreement and Supply Agreement with Par were terminated.  The License Agreement was terminated and all rights under the license granted to Par revert back to us under the Termination Agreement.  Under the Supply Agreement, we had agreed to supply all of Par’s requirements for ONCONASE®. Pursuant to the Termination Agreement, Par will be entitled to a royalty of 2% of net sales of ONCONASE® or any other ranpirnase product developed by us for use in the treatment of cancer in the United States and its territories commencing with the first sale of such product and terminating upon the later to occur of the 12th anniversary of the first sale and the date of expiration of the last valid claim of a pending application or issued patent owned or controlled by us with respect to such product.

Marketing and Distribution Agreements

Megapharm Ltd.
 
In May 2008, we entered into an exclusive marketing, sales and distribution agreement with Megapharm Ltd. for the commercialization of ONCONASE® in Israel.  Under the agreement, we are eligible to receive 50% of net sales in the territory.  We will be responsible for the manufacture and supply of ONCONASE® to Megapharm, while Megapharm will be responsible for all activities and costs related to regulatory filings and commercial activities in the territory.

 
11

 
 
BL&H Co.  Ltd.

In January 2008, we entered into a marketing and distribution agreement with BL&H Co. Ltd. for the commercialization of ONCONASE® in Korea, Taiwan and Hong Kong. Under the agreement, we received a $100,000 up-front fee and are eligible to receive additional cash milestones and 50% of net sales in the territory. We will be responsible for the manufacture and supply of ONCONASE® to BL&H, while BL&H will be responsible for all activities and costs related to regulatory filings and commercial activities in the territory.

US Pharmacia

In July 2007,  we entered into a Distribution and Marketing Agreement (the “Distribution Agreement”), with USP Pharma Spolka Z.O.O. (the “Distributor”), an affiliate of US Pharmacia, pursuant to which the Distributor was granted exclusive rights for the marketing, sales, and distribution of ONCONASE® for use in oncology in Poland, Belarus, Ukraine, Estonia, Latvia, and Lithuania (the “Territory”) for an initial term that ends upon the earlier of (i) 10 years from the first commercial sale in the Territory and (ii) the date all of the patents covering the product in the Territory expire.  We received an up-front payment of $100,000 and will also be entitled to receive milest one payments based on the achievement of certain regulatory approvals and certain sales goals.  In addition, we will receive a royalty on net sales as well as a transfer price for product sold by us to the Distributor. We will be responsible for making regulatory filings with and seeking marketing approval of ONCONASE® in the Territory and manufacturing and supplying ONCONASE® to the Distributor.  The Distributor will be responsible for all commercial activities and related costs in the Territory.

In connection with the Distribution Agreement, we also entered into a Securities Purchase Agreement, with Unilab LP, an affiliate of US Pharmacia, pursuant to which we issued a total of 553,360 shares of restricted common stock for approximately $1.4 million, or $2.53 per share.

GENESIS Pharma S.A.

In December 2006,  we entered into a Distribution and Marketing Agreement with GENESIS Pharma S.A. (“GENESIS”), pursuant to which GENESIS was granted exclusive rights for the marketing, sales, and distribution of ONCONASE® for use in oncology in Greece, Cyprus, Bulgaria, Romania, Slovenia, Croatia, Serbia, and the Former Yugoslavian Republic of Macedonia (the “Region”) for an initial term that ends upon the earlier of (i) 10 years from the first commercial sale in the Region and (ii) the date all of the patents covering the product in the Region expire.  We will retain ownership of all intellectual property relating to ONCONASE® and responsibility for all regulatory filings with EMEA in the European Union (EU), with GENESIS providing assistance with regard to regulatory filings in the non-EU countries included in this agreement.  We will also be responsible for manufacturing and supplying the product to GENESIS, which will distribute the product.  GENESIS will have lead responsibility for all ONCONASE® commercialization activities and will manage all operational aspects of the marketing, sales and distribution of the product in the Region.  We are entitled to receive milestone payments based on the achievement of certain regulatory approvals and certain sales goals.  In addition, we will receive a royalty on net sales as well as a transfer price for product sold by us to GENESIS.

Manufacturing

In January 2008, we entered into a Purchase and Supply Agreement (the “Supply Agreement”) with Scientific Protein Laboratories LLC (“SPL”). Under the Supply Agreement, SPL will manufacture and be our exclusive supplier for the bulk drug substance used to make ONCONASE®.  The term of the Supply Agreement shall be ten years and we have the right to terminate the Supply Agreement at any time without cause on two years prior notice to SPL.

Additionally, we contract with Ben Venue Laboratories Inc. (“Ben Venue”) for vial filling and with Bilcare Global Clinical Supplies, Americas (“Bilcare”), Aptuit, Inc. (“Aptuit”) and Catalent Pharma Solutions, Inc. (“Catalent”) for the labeling, storage and shipping of ONCONASE® for use in clinical trials.  Other than these arrangements we do not have specific arrangements for the manufacture of ONCONASE®.

 
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Products manufactured for use in clinical trials and for commercial sale must be manufactured in compliance with Current Good Manufacturing Practices (“CGMP”).  SPL, Ben Venue, Aptuit and Catalent are all licensed or approved by the appropriate regulatory agencies and all work is performed in accordance with CGMP.  For the foreseeable future, we intend to rely on these manufacturers and related service providers, or substitute vendors, if necessary, to manufacture our product.  We believe, however, that there are substantial alternative providers for the services for which we contract.  For those relationships where we have not entered into formal agreements, we utilize the services of these third party contractors solely on an as needed basis with prices and terms customary for companies in businesses that are similarly situated.  In order to replace an existing manufacturer, we must amend our Investigational New Drug application to notify the appropriate regulatory agencies of the change.  We are dependent upon our contract manufacturers to comply with CGMP and to meet our production requirements. It is possible that our contract manufacturers may not comply with CGMP or deliver sufficient quantities of our products on schedule, or that we may be unable to find suitable and cost effective alternative providers if necessary.

Raw Materials

The major active ingredient derived from leopard frog eggs is the protein ranpirnase.  We believe we have sufficient egg inventory on hand to produce enough ONCONASE® for our future clinical trials and early commercialization.  In addition, we have successfully produced ranpirnase in small proof-of-concept size batches using recombinant technology.  However, this technology requires additional testing and FDA approval and it may be determined to not be more cost effective than current methods of production.

Patents and Proprietary Technology

We have sought to protect our technology by applying for, and obtaining, patents and trademark registrations.  We have also relied on trade secrets and know-how to protect our proprietary technology.  We continue to develop our portfolio of patents, trade secrets, and know how.  We have obtained, and continue to apply for, patents concerning our RNase-based technology.

In addition, we have filed (and we intend to continue to file) foreign counterparts to certain U.S. patent applications. Generally, we apply for patent protection in the United States, Europe, Japan, and certain other foreign countries.

We own the following U.S. patents:

Patent No.
 
Issue Date
Subject Matter
Expiration **
5,529,775
  June 1996
covers combinations of ONCONASE® with certain other pharmaceuticals
June 2013
5,728,805
  Mar. 1998
covers a family of variants of ONCONASE®
June 2013
5,540,925
  July 1996
covers combinations of ONCONASE® with certain other pharmaceuticals
July 2013
5,559,212
  Sept. 1996
covers the amino acid sequence of ONCONASE®
Sept. 2013
5,595,734
  Jan. 1997
covers combinations of ONCONASE® with certain other pharmaceuticals
Jan. 2014
6,649,392 B1*
  Nov. 2003
covers a family of recombinant variants of ONCONASE®
Apr. 2016
6,649,393 B1*
  Nov. 2003
covers nucleic acids encoding recombinant variants of ONCONASE® and methodology for producing such variants
Apr. 2016
6,290,951 B1
  Sept. 2001
covers alteration of the cell cycle in vivo, particularly for inducing apoptosis of tumor cells
Aug. 2018
6,239,257 B1
  May 2001
covers a family of variants of ONCONASE®
Dec. 2018
6,175,003 B1
  Jan. 2001
covers the genes of ONCONASE® and a variant of ONCONASE®
Sept. 2019
 
 
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Patent No.
 
Issue Date Subject Matter Expiration ** 
6,423,515 B1
  July 2002
covers methodology for synthesizing gene sequences of ONCONASE® and a genetically engineered variant of ONCONASE®
Sept. 2019
7,229,824 B1***
  June 2007
covers a vector containing DNA encoding a genetically engineered Amphinase
May 2024
7,556,952 B2
  July 2009
covers a gene encoding a genetically engineered Amphinase
July 2023
7,556,951 B2
  July 2009
covers a gene encoding a genetically engineered Amphinase , and a vector containing DNA encoding a genetically engineered Amphinase
July 2023
7,556,953 B2
  July 2009
covers a gene encoding a genetically engineered Amphinase, and a vector containing DNA encoding a genetically engineered Amphinase
July 2023
7,442,535 B2
  October 2008
covers a fusion protein containing a genetically engineered Amphinase
July 2023
7,585,655 B2
  September 2009
covers a gene encoding a genetically engineered Amphinase, and a vector containing DNA encoding it
July 2023
7,442,536 B2
  October 2008
covers genetically engineered Amphinases
July 2023
7,585,654 B2
  September 2009
covers a vector containing DNA encoding a genetically engineered Amphinase, and a gene encoding a genetically engineered Amphinase
July 2023
7,473,542 B2
  January 2009
Covers a fusion protein containing a genetically engineered Amphinase
July 2023
7,763,449 B2
  July 2010
covers a vector containing DNA encoding a genetically engineered Amphinase, and a gene encoding a genetically engineered Amphinase
July 2023

*We own this patent jointly with the U.S. Government.  We do not pay maintenance fees to keep this patent in force.

Tamir now uses the term “Amphinase” to describe a family of proteins.  ONCONASE®, and proteins in the Amphinase family, belong to the same superfamily of Ribonucleases.  Amphinase proteins were previously referred to as ‘variants” of ONCONASE®.

We own the following foreign patents in Europe (European patents are validated in selected European nations), Japan and Singapore:

Patent No.
 
Subject Matter
Expiration **
EP 0 500 589
JP 2972334
cover combinations of  ONCONASEâ with certain other pharmaceuticals
Oct. 2010
EP 0 656 783
JP 3655628
covers combinations of  ONCONASEâ with certain other pharmaceuticals
July 2013
EP 0 837 878
JP 3779999
covers a variant of ONCONASEâ and a method of producing it
June 2016
EP 1 141 004
JP 4516216
covers a family of variants of ONCONASE®
December 2019
SG 118886
covers Amphinases and methods of making them
May 2024

**Assumes timely payment of all applicable maintenance fees and annuities; excludes term extensions that do or may apply.

 
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***Includes a term extension of 312 days under 35 U.S.C. §154(b).

We also have patent applications pending in the United States, Europe, Japan, and other foreign countries.

The scope of protection afforded by patents for biotechnological inventions can be uncertain, and such uncertainty may apply to our patents as well.  The patent applications we have filed, or that we may file in the future, may not issue as patents.  Our patents may not give us a competitive advantage, may be wholly or partially invalidated or held unenforceable, or may be held not to have been infringed by products that compete with our products.  Patents owned by others may adversely affect our ability to do business.  Furthermore, others may independently develop products that are similar to our products or that duplicate our products, and may design around the claims of our patents.  Although we believe that our patents and patent applications are of substantial value to us, we cannot assure you that such patents and patent applications will be of commercial benefit to us, will adequately protect us from competing products or will not be challenged, declared invalid, or found not to have been infringed by competing products.  We also rely on proprietary know-how and on trade secrets to develop and maintain our competitive position.  Others may independently develop or obtain access to such know-how or trade secrets.  Although our employees and consultants having access to proprietary information are required to sign agreements that require them to keep such information confidential, our employees or consultants may breach these agreements or these agreements may be held to be unenforceable.

Government Regulation

The manufacturing and marketing of pharmaceutical products in the United States require the approval of the FDA under the Federal Food, Drug and Cosmetic Act.  Similar approvals by comparable regulatory agencies are required in most foreign countries. The FDA has established mandatory procedures and safety standards that apply to the clinical testing, manufacturing and marketing of pharmaceutical products in the United States. Obtaining FDA approval for a new therapeutic may take many years and involve substantial expenditures.  State, local and other authorities also regulate pharmaceutical manufacturing facilities.

As the initial step in the FDA regulatory approval process, preclinical studies are conducted in laboratory dishes and animal models to assess the drug's efficacy and to identify potential safety problems. Moreover manufacturing processes and controls for the product are required.  The manufacturing information along with the results of these studies is submitted to the FDA as a part of the Investigational New Drug Application, or IND, which is filed to obtain approval to begin human clinical testing. The human clinical testing program typically involves up to three phases. Data from human trials as well as other regulatory requirements such as chemistry, manufacturing and controls, pharmacology and toxicology sections, are submitted to the FDA in an NDA or Biologics License Application, or BLA.   ;Preparing an NDA or BLA involves considerable data collection, verification and analysis.  A similar process in accordance with EMEA regulations in Europe and with TGA regulations in Australia is required to gain marketing approval.  Moreover, a commercial entity must be established and approved by the EMEA in a member state of the EU at least three months prior to filing the Marketing Authorization Application, or MAA.

We have not received United States or other marketing approval for any of our product candidates and may not receive any approvals.  We may encounter difficulties or unanticipated costs in our effort to secure necessary governmental approvals, which could delay or preclude us from marketing our products.

With respect to patented products, delays imposed by the governmental approval process may materially reduce the period during which we may have the exclusive right to exploit them.

Environmental Matters

Our operations are subject to comprehensive regulation with respect to environmental, safety and similar matters by the United States Environmental Protection Agency and similar state and local agencies. Failure to comply with applicable laws, regulations and permits can result in injunctive actions, damages and civil and criminal penalties. If we expand or change our existing operations or propose any new operations, we may need to obtain additional or amend existing permits or authorizations.  We spend time, effort and funds in operating our facilities to ensure compliance with environmental and other regulatory requirements.

 
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Such efforts and expenditures are common throughout the biotechnology industry and generally should have no material adverse effect on our financial condition.  The principal environmental regulatory requirements and matters known to us requiring or potentially requiring capital expenditures by us do not appear likely, individually or in the aggregate, to have a material adverse effect on our financial condition.  We believe that we are in compliance with all current laws and regulations.

Employees

As of July 31, 2010, we had four full time employees, of whom three were engaged in clinical and pre-clinical research and development activities and one was engaged in administration and management.  Two employees hold Ph.D. degrees.  All of our employees have entered into confidentiality agreements with us.  We consider relations with our employees to be good.  None of our employees are covered by a collective bargaining agreement.

Available Information
 
Copies of our annual report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 are available free of charge through our website (www.tamirbio.com) as soon as reasonably practicable after we electronically file the material with, or furnish it to, the Securities and Exchange Commission (the “SEC”). You may read and copy any document we file with the SEC at the SEC’s Public Reference Room at 100 F Street, N.E., Washington, DC 20549. Please call the SEC at 1-800-SEC-0330 for further information on the Public Reference Room. Our SEC filings are also available to the public at the SEC’s website at http://www.sec. gov. Additionally, we have also adopted a Code of Business Conduct and Ethics applicable to all officers, directors, and employees, which is also available on our website.

 
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ITEM 2.  PROPERTIES.

In March 2007, we entered into a lease for 15,410 square feet in an industrial office building located in Somerset, New Jersey to replace our facility in Bloomfield, New Jersey as our principal office.  The lease term commenced on July 3, 2007 and is scheduled to terminate on November 30, 2017.  The average monthly rental obligation over the full term of the lease is approximately $25,000.  In January 2010, we vacated this facility.  In February 2010, the landlord, I&G Garden State, LLC ("I&G"), withdrew the remaining balance of the Company’s secured irrevocable letter of credit which was placed in March 2007 in the amount of approximately $81,000.  On February 5, 2010, I&G commenced an action against us.  The lawsuit seeks unspecifie d damages for an alleged breach of a lease agreement dated March 14, 2007 between us and I&G.  On or before November 1, 2010, we entered into a Settlement Agreement and Mutual Release with I&G whereas I&G agreed to receive $200,000 in consideration of the full release in full and and complete settlement of all claims made by I&G.

On January 15, 2010, Mr. Muniz, as an individual, entered into a quarterly lease agreement with I&G for office space at the fourth floor of 300 Atrium Drive, Somerset, NJ, which space we will occupy as our new office.  The lease expired on September 30, 2010 but was renewable for successive three-month periods upon thirty days prior notice and payment of $15,790.50 for the following three months’ rent.  We did not renew this lease upon its expiration.
 
On September 28, 2010, we entered into an office lease agreement effective as of October 1, 2010, with Princeton Corporate Plaza, LLC for $3,794 per month including expenses.  We leased 2,046 square feet of office and laboratory space in the building located at 11 Deer Park Drive, Suite 204, in the township of South Brunswick in the County of Middlesex, State of New Jersey.  The new office replaced 300 Atrium Drive, Somerset, New Jersey 08873 as our principal executive offices. The lease term began on October 1, 2010, ending on September 30, 2011.  We believe that this facility is sufficient for our needs in the foreseeable future.
 
ITEM 3.  LEGAL PROCEEDINGS.
 
On October 1, 2010, Robert Love, a former Chief Financial Officer and alleged shareholder of the Company, filed an amended complaint in Love v. Alfacell Corp. et al., Case No. 3:09-cv-05199-MLC-LHG (the “Amended Complaint”), against the Company and certain of its current and former directors in the United States District Court, District of New Jersey, asserting violations of federal and state securities laws, direct and derivative common law claims for fraud and breach of fiduciary duty, a direct claim for negligent misrepresentation and derivative claims for gross negligence and corporate waste in connection with the Company’s Phase IIIb clinical trial for ONCONASE®.  The Amended Complaint alleges that the Company misled shareholders by issuing allegedly false projections of when the required number of patient deaths would occur in the Phase IIIb trial.  The Amended Complaint seeks compensatory damages of no less than $350,000, punitive damages of no less than $20 million, and an accounting and constructive trust.  The Company believes that the claims are meritless and intends to defend the case vigorously.

Premier Research Group filed and served a lawsuit against the Company in the Superior Court of New Jersey, Law Division, Essex County, on or about July 26, 2009, seeking the recovery of professional fees that arose from clinical trials purportedly performed in Europe by Premier Research Group as assignee of a contract between Tamir Biotechnology, Inc. and IMFORM GmbH dated October 27, 2005.  An Answer with Separate Defenses and Counterclaim was filed on or about July 30, 2009.  In August 2010, both parties entered into a Stipulation of Settlement Agreement (“Stipulation”) whereby the Company will make a payment to Premier in the amount of $100,000 which will be accepted as a payment in full if paid in accordance with the terms of the Stipulation.  The settlement will be paid every 60 days in four equal installments commencing on or before August 6, 2010, ending on or before February 7, 2011.

I & G Garden State, LLC (“I&G”) filed and served a complaint against the Company in the Superior Court of New Jersey Law Division, Special Civil Part Landlord-Tenant Section, Somerset County, on or about October 30, 2009, for non-payment of rent and failure to maintain security deposit.  The complaint seeks to have the Company vacate the property.  On November 13, 2009, the Company and I&G mutually agreed that the Company would vacate the property on or before December 31, 2009.  In January 2010, the Company vacated the facility as per mutual agreement.  In February 2010, I&G withdrew the remaining balance of the Company’s secured irrevocable letter of credit which was placed in March 2007 in the amount of approximately $81,000.  On February 5, 2010, I&G commenced an action against the Company.  The lawsuit seeks unspecified damages for an alleged breach of a lease agreement dated March 14, 2007 between the Company and I & G.  On or before November 1, 2010, the Company and I&G entered into a Settlement Agreement and Mutual Release whereas I&G agreed to receive $200,000 in consideration of the release in full and complete settlement of all claims made by I&G.

 
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ITEM 4.  RESERVED.
 

PART II

ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
 
Our common stock has been quoted on the Pink Sheets since our delisting from the Nasdaq Capital Market, or Nasdaq, on January 6, 2009 for failure to comply with the $35 million minimum market value requirement under Marketplace Rule 4310(c)(3)(B) or the $1 per share minimum bid price requirement under Marketplace Rule 4310(c)(4).  In addition, we also did not meet the $2.5 million minimum stockholders’ equity requirement under Marketplace Rule 4310(c)(3)(A) or the requirement for a minimum net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years under Marketplace Rule 4310(c)(3)(C).  Our common stock remains thinly traded at times and you may b e unable to sell our common stock during times when the trading market is limited. As of October 25, 2010, there were approximately 968 stockholders of record of our common stock.
 
Prior to January 6, 2009, our common stock was listed on Nasdaq and had traded under the symbol "ACEL" since September 9, 2004.  Before September 9, 2004, our common stock was traded on the OTC Bulletin Board (OTCBB).
 
The following table sets forth the range of high and low sale prices of our common stock for the two fiscal years ended July 31, 2010 and 2009.  The prices were obtained from Pink Sheets and Nasdaq, and are believed to be representative of inter-dealer prices, without retail mark-up, mark-down or commission, and may not necessarily represent actual transactions.

   
High
   
Low
 
Year Ended July 31, 2010:
           
First Quarter
  $ 0.35     $ 0.18  
Second Quarter
    0.30       0.14  
Third Quarter
    0.35       0.11  
Fourth Quarter
    0.30       0.13  
                 
Year Ended July 31, 2009:
               
First Quarter
    0.85     $ 0.40  
Second Quarter
    0.54       0.08  
Third Quarter
    0.20       0.06  
Fourth Quarter
    0.52       0.11  
 
 
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Dividends
 
We have not paid dividends on our common stock since inception, and we do not plan to pay dividends in the foreseeable future.  Any earnings we may realize will be retained to finance our growth.  Additionally, pursuant to the terms of the Senior Secured Notes issued in connection with our October 2009 private financing, we are not permitted to declare or pay any cash dividends or distributions on its outstanding capital stock for so long as the Senior Secured Notes are outstanding.

Equity Compensation Plan Information

The information called for by Item 5(a) relating to compensation plan information is incorporated herein by reference to Item 12—Security Ownership of Certain Beneficial Owners and Management and Related Stock Matters of this annual report on Form 10-K.

Recent Sales of Unregistered Securities
 
None

Issuer Purchases of Equity Securities
 
There were no repurchases of our equity securities made by us or on our behalf, or by any “affiliated purchasers” during the quarter ended July 31, 2010.

 
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ITEM 7.  MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

The following discussion of our financial condition and results of operations should be read together with our consolidated financial statements and notes to those statements included in Item 8 of Part II of this annual report on Form 10-K.
 
Overview

We are a biopharmaceutical company engaged in the research, development, and commercialization of drugs for life threatening-diseases, such as malignant mesothelioma and other cancers.  Our corporate strategy is to become a leader in the discovery, development, and commercialization of novel ribonuclease (RNase) therapeutics for cancer and other life-threatening diseases.
          
We are a development stage company as defined in the Accounting Standards Codification (“ASC”) Topic “Development Stage Entities”.  We are devoting substantially all of our present efforts to establishing a new business and developing new drug products. Our planned principal operations of marketing and/or licensing new drugs have not commenced and, accordingly, we have not derived any significant revenue from these operations.
 
Since our inception in 1981, we have devoted the vast majority of our resources to the research and development of ONCONASE®, our lead drug candidate, as well as other related drug candidates.  In recent years we have focused our resources towards the completion of the clinical program for ONCONASE® in patients suffering from unresectable malignant mesothelioma, or UMM.

During our fiscal year ended July 31, 2010, our efforts were primarily focused on the completion of our confirmatory Phase IIIb clinical trial for UMM and preparation of the remaining components of our NDA.  As we previously reported, the results of the preliminary statistical analysis of the data from the confirmatory Phase IIIb clinical trial for ONCONASE® in patients suffering from UMM did not meet statistical significance for the primary endpoint of survival in UMM.  However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen, a currently unmet medical need and one of the predefined primary sub-group data sets for patients in the trial.  At the pre-NDA meeting with the FDA in January 2009, the FDA recommended that an additional clinical trial be conducted in UMM patients that have failed one prior chemotherapy regimen, prior to filing an NDA.  At this time, we intend to explore opportunities involving  further clinical trials for ONCONASE® for the UMM indication as a second line therapy.  Other indications are being pursued including lung cancer and other solid tumors and currently we expect to use the proceeds we received from the private financing we closed in October 2009 to initiate a Phase II clinical trial of ONCONASE® for the treatment of non-small cell lung cancer in patients who have reached maximum progression after receiving two cycles of Alimta in combination with carboplatinum.  We anticipate accruing t he first patient for this trial in late 2010.
 
During the fiscal year ended July 31, 2010, we completed a sale of 65 Units in a private financing to certain investors pursuant to a securities purchase agreement (the “Securities Purchase Agreement”) entered into on October 19, 2009. Each Unit consists of (i) $50,000 principal amount of Senior Secured Notes convertible into shares of the Company’s common stock at a price of $0.15 per share, (ii) Series A Warrants to purchase in the aggregate that number of shares of common stock initially issuable upon conversion of the aggregate amount of the Senior Secured Notes issued as part of the Unit, at an exercise price of $0.15 per share with a three year term and (iii) Series B Warrants to purchase in the aggregate that number of shares of common stock initially issuable upon conversion of the aggregate amount of the Senior Secured Notes issued as part of the Unit, at an exercise price of $0.25 per share with a five year term. The closing of the private financing occurred on October 19, 2009, and we received an aggregate of $3,250,000 in gross proceeds.  (See Notes to the Financial Statements – Note 6)

During the fiscal year ended July 31, 2010, at the annual stockholders’ meeting, our stockholders approved an amendment to our Certificate of Incorporation, as amended, changing the name of the company from Alfacell Corporation to Tamir Biotechnology, Inc. and increasing our authorized common stock from 100,000,000 to 250,000,000 shares.

 
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Almost all of the $73.1 million of research and development expenses we have incurred since our inception has gone toward the development of ONCONASE® and related drug candidates.  For the fiscal years 2010 and 2009, our research and development expenses were approximately $0.5 million and $3.3 million, respectively, almost all of which were used for the development of ONCONASE® and related drug candidates.

 We have incurred losses since inception and we have not received FDA approval of any of our drug candidates.  We expect to continue to incur losses for the foreseeable future as we continue our efforts to receive marketing approval for our drug candidates, which includes the sponsorship of human clinical trials.  Until we are able to consistently generate revenue through the sale of drug or non-drug products, we anticipate that we will be required to fund the development of our pre-clinical compounds and drug product candidates primarily by other means, including, but not limited to, licensing the development or marketing rights to some of our drug candidates to third parties, collaborating with third parties to develop our drug candidat es, or selling Company issued securities.

We fund the research and development of our products primarily from cash receipts resulting from the sale of our equity securities and convertible debentures in registered offerings and private placements.  Additionally, we have raised capital through other debt financings, the sale of our tax benefit and research and development credits, interest income and financing received from Kuslima Shogen, our former Chief Executive Officer.  During the fiscal year ended July 31, 2010, we received gross proceeds of $3.25 million from a private financing and $646,649 from the sale of our tax benefit.  These proceeds will be used to continue our operations, explore strategic alternatives and initiate a Phase II clinical study for non-small cell lung cancer in patients who have reached maximum prog ression on their current chemotherapy regimens.  We have incurred losses since inception and, to date, we have generated only small amounts of capital from commercial agreements for ONCONASE®.

Results of Operations

Fiscal Year Ended July 31, 2010, as compared to Fiscal Year Ended July 31, 2009
 
We are a development stage company as defined in the Accounting Standards Codification (“ASC”) Topic “Development Stage Entities”.  We are devoting substantially all of our present efforts to establishing a new business and developing new drug products. Our planned principal operations of marketing and/or licensing new drugs have not commenced and, accordingly, we have not derived any significant revenue from these operations.  We focus most of our productive and financial resources on the development of ONCONASE®.  We did not record any significant revenue in fiscal years 2010 or 2009.

Research and development expense for fiscal year 2010 was $0.5 million compared to $3.3 million for fiscal year 2009, a decrease of approximately $2.8 million, or 84%.  The decrease was primarily related to decreased expenses of approximately $1.9 million related to costs incurred in fiscal year 2009 for the ONCONASE® rolling NDA submission for our Phase IIIb clinical trial for malignant mesothelioma; and decreased compensation expense of approximately $0.9 million from reduction in force and decreased share-based compensation.
 
General and administrative expense for fiscal year 2010 was approximately $1.7 million compared to approximately $2.4 million for fiscal year 2009, a decrease of approximately $0.7 million, or 34%.  This decrease was primarily related to decreased compensation expense of approximately $0.4 million from decreased share-based compensation expense, retirement of Kuslima Shogen, our former chief executive officer and resignation of Lawrence Kenyon, our former chief financial officer.  Public relations-related costs and other general office expenses also decreased by approximately $0.3 million due to our reduced operations in fiscal year 2010.
 
Investment income for fiscal year 2010 was approximately $1,000 compared to $26,000 for fiscal year 2009, a decrease of $25,000.  The decrease was due to lower balances of cash and cash equivalents on hand during the fiscal year 2010 as compared to the same period in 2009.

Interest expense for the fiscal year ended July 31, 2010 increased by approximately $12.6 million compared to the same period last year.  This increase was directly due to the beneficial conversion feature of the convertible debenture and warrants we issued in October 2009, the original recognition of and the change in valuation of the derivative liability.
 
 
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New Jersey has enacted legislation permitting certain corporations located in New Jersey to sell a portion of its state tax loss carryforwards and state research and development credits in order to obtain tax benefits.  For the state fiscal year 2010 (July 1, 2009 to June 30, 2010), we had approximately $723,000 of total available state tax benefit that was saleable.  In February 2010, we received approximately $647,000 from the sale of our total available state tax benefit, which was recognized as state tax benefit in the fiscal year ended July 31, 2010.
 
We have incurred net losses during each year since our inception.  The net loss for fiscal year 2010 was approximately $14.2 million as compared to $4.5 million in fiscal year 2009.  The cumulative loss from the date of inception, August 24, 1981 to July 31, 2010, amounted to $123 million.  Such losses are attributable to the fact that we are still in the development stage and, accordingly, have not derived sufficient revenues from operations to offset the development stage expenses.

Liquidity and Capital Resources

We have reported cumulative net losses of approximately $31 million for the three most recent fiscal years ended July 31, 2010.  The net losses from date of inception, August 24, 1981 to July 31, 2010, amounts to approximately $123 million.  As of July 31, 2010, we have a working capital deficit of approximately $15 million.

We have financed our operations since inception primarily through the sale of our equity securities and convertible debentures in registered offerings and private placements.  Additionally, we have raised capital through other debt financings, the sale of our state tax benefit and research products, and investment income and financing received from Kuslima Shogen, our former Chief Executive Officer.  As of July 31, 2010, we had approximately $0.3 million in cash and cash equivalents.  We currently believe that our cash reserves including the $1.2 million restricted cash intended for future clinical trials can support our activities through April 2011, based upon our reduced operations.

The primary use of our cash will be to fund our clinical and pre-clinical research and development efforts for ONCONASEâ.  The most significant expenses will be incurred for the Phase II clinical study for non-small cell lung cancer.  Additional expenses are also expected to be incurred as we continue to move our drug product candidates towards the next phase of clinical and pre-clinical development.  We will need to obtain additional financing in order to continue our operations.  Given current market conditions, it may be very difficult, if not impossible, to obtain such financing.  In order to continue our operations we will need to pursue strategic alternative s for the further development of ONCONASE®.
 
During the fiscal year ended July 31, 2010, we completed a sale of 65 Units in a private financing to certain investors pursuant to a securities purchase agreement (the “Securities Purchase Agreement”) entered into on October 19, 2009. Each Unit consists of (i) $50,000 principal amount of Senior Secured Notes convertible into shares of the Company’s common stock at a price of $0.15 per share, (ii) Series A Warrants to purchase in the aggregate that number of shares of common stock initially issuable upon conversion of the aggregate amount of the Senior Secured Notes issued as part of the Unit, at an exercise price of $0.15 per share with a three year term and (iii) Series B Warrants to purchase in the aggregate that number of shares of common stock initially issuable upon conversion of the aggregate amount of the Senior Secured Notes issued as part of the Unit, at an exercise price of $0.25 per share with a five year term. The closing of the private financing occurred on October 19, 2009, and the Company received an aggregate of $3,250,000 in gross proceeds.
 
Pursuant to the terms of the Securities Purchase Agreement, certain investors party thereto are permitted to appoint a designee to the Board of Directors (the “Board”) within a reasonable period of time following the closing of the private financing.  In addition, as a condition to closing the private financing, each member of the Board other than David Sidransky, Chairman of the Board, and Charles Muniz, agreed to resign from the Board upon the request of Dr. Sidransky made at any time following the closing of the private financing and prior to December 31, 2009.  Donald Conklin and Kuslima Shogen resigned from the Board during the fiscal year ended July 31, 2010.  Stephen Carter did not seek reelection at our annual meeting of the stockholders, which occurred on April 27, 2010.
 
 
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In connection with the private financing, we entered into the Investor Rights Agreement with each of the investors. The Investor Rights Agreement provides that we will file a “resale” registration statement covering all of the shares issuable upon conversion of the Senior Secured Notes and the shares issuable upon exercise of the Warrants, up to the maximum number of shares able to be registered pursuant to applicable SEC regulations, by May 1, 2010, which date was extended from February 16, 2010 pursuant to an amendment to the Investor Rights Agreement we entered into with the investors on February 26, 2010 and reported on Form 8-K we filed on March 4, 2010.  In accordance with the Investor Rights Agreement, on April 30, 2010, the Company filed w ith the SEC a “resale” registration statement on Form S-1.  If any of the securities issuable upon conversion or exercise, respectively, of the Senior Secured Notes and Warrants are unable to be included on the initial “resale” registration statement, we agreed to file subsequent registration statements until all the securities have been registered.  Under the terms of the Investor Rights Agreement, we are obligated to maintain the effectiveness of the “resale” registration statement until all securities therein are sold or otherwise may be sold by non-affiliates pursuant to Rule 144 of the Securities Act, without restrictions. A cash penalty of 1% per month will be triggered in the event we fail to file or obtain the effectiveness of a registration statement prior to the deadlines set forth in the Investor Rights Agreement, which deadlines were extended by the amendment to the Investor Rights Agreement, or if we cease to be current in filing our period ic reports with the SEC.  The aggregate penalty accrued with respect to each investor may not exceed 6% of the original purchase price paid by that investor, or 12% if the only effectiveness failure is our failure to be current in our periodic reports with the SEC.
 
On July 31, 2010, we entered into a second amendment to the Investor Rights Agreement with the investors, pursuant to which the investors waived their right to receive penalties in respect of all matters occurring prior to the date of the second amendment, which included our failure to obtain the effectiveness of a registration statement within the deadlines set forth in the Investor Rights Agreement. In addition, the second amendment postponed the investors right to require the company to file a "resale" registration statement covering all of the shares issuable upon conversion of the Senior Secured Notes and the shares issuable upon exercise of the Warrants until after our next financing which yields gross proceeds to us of at least $3,250,000. In the event of such a financing, and following a written demand made by the holders of the majority of the registrable securities, we must file, within 90 days of our receipt of the demand notice, either a new "resale" registration statement registered the shares or amend the registration statement we filed on April 30, 2010. A copy of the second amendment is filed as Exhibit 10.55 to this annual report on Form 10-K.

In connection with the private placement, we also entered into an escrow agreement whereby certain investors placed $1,600,000 of the proceeds paid for their Units in an escrow account pursuant to the terms of the Securities Purchase Agreement.  Such amounts can be disbursed from the escrow account only to satisfy obligations we owed to clinical research organizations, hospitals, doctors and other vendors and service providers associated with the clinical trials which we intend to conduct for our ONCONASEâ product. The escrow agreement shall terminate on the earlier of the date that all funds have been disbursed from the escrow account or April 19, 2011, at which time any remaining funds will be disbursed to us.

In connection with our private financing completed in October 2009, we issued $3.25 million of Senior Secured Notes convertible into shares of our common stock at a price of $0.15 per share.  The Senior Secured Notes mature on the earlier of (i) October 19, 2012; (ii) the closing of a public or private offering of our debt or equity securities subsequent to the date of issuance resulting in gross proceeds of at least $8,125,000 other than a transaction involving a stockholder who holds 5% or more of our outstanding capital stock as of the date of issuance; or (iii) on the demand of the holder of the Senior Secured Note upon our consummation of a merger, sale of substantially all of our assets, or the acquisition by any entity, person or group of 50% or more of our voting power.  Interest accrues on the principal amount outstanding under the Senior Secured Notes at 5% per annum, and is due upon maturity.  Upon an event of default under the Notes, the interest rate shall increase to 7%.  The Senior Secured Notes are not prepayable for a period of one year following the issuance thereof.  The Senior Secured Notes are secured by a senior security interest and lien on all of our right, title and interest to all of the assets owned by us as of the closing of the private financing or thereafter acquired pursuant to the terms of a security agreement we entered into with each of the investors.
 
For so long as the Senior Secured Notes are outstanding, we are not permitted, among other restrictions, to liquidate or dissolve, consolidate with or merge into or with any other corporation, to sell our assets, other than in the ordinary course of business, redeem or repurchase any outstanding equity or debt securities, create or incur any indebtedness which is not subordinate to the Senior Secured Notes or create liens on our assets with certain exceptions.

 
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Our audited financial statements for the fiscal year ended July 31, 2010, were prepared under the assumption that we will continue our operations as a going concern.  We were incorporated in 1981 and have a history of losses and negative cash flows from operating activities.  As a result, our independent registered public accounting firm in their audit report has expressed substantial doubt about our ability to continue as a going concern. Continued operations are dependent on our ability to raise additional capital from various sources such as those described above.  Such capital raising opportunities may not be available or may not be available on reasonable terms.  Our financial statements do not include any adjustments that may result from the outcome of this uncertainty.< /font>
 
We may seek to satisfy future funding requirements through public or private offerings of securities or with collaborative or other arrangements with corporate partners.  Additional financing or strategic transactions may not be available when needed or on terms acceptable to us, if at all.  If adequate financing is not available, we may be required to delay, scale back, or eliminate certain of our research and development programs, relinquish rights to certain of our technologies, drugs or products, or license third parties to commercialize products or technologies that we would otherwise seek to develop ourselves.

Off-Balance Sheet Arrangements

We have no debt, no exposure to off-balance sheet arrangements, no special purpose entities, nor activities that include non-exchange-traded contracts accounted for at fair value as of July 31, 2010.
 
Critical Accounting Policies

In December 2001, the SEC requested that all registrants discuss their most "critical accounting policies" in Item 7 - Management's Discussion and Analysis of Financial Condition and Results of Operations. The SEC indicated that a "critical accounting policy" is one which is both important to the portrayal of the company's financial condition and results and requires management's most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.   The accounting policies set forth below have been considered critical because changes to certain judgments, estimates and assumptions could significantly affect our financial statements.

Use of Estimates
 
The preparation of financial statements in conformity with U.S. generally accepted accounting principles or GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting period.  Actual results could differ from those estimates.

 
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Revenue Recognition
 
We recognize revenue in accordance with Staff Accounting Bulletin (“SAB”) No. 104, “Revenue Recognition,” issued by the staff of the SEC.  Under SAB No. 104, revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred and/or services have been rendered, the sales price is fixed or determinable, and collectibility is reasonably assured.
 
We enter into marketing and distribution agreements, which contain multiple deliverables.  We evaluate whether these deliverables constitute separate units of accounting to which total arrangement consideration is allocated.  A deliverable qualifies as a separate unit of accounting when the item delivered to the customer has standalone value, there is objective and reliable evidence of fair value of items that have not been delivered to the customer, and, if there is a general right of return for the items delivered to the customer, delivery or performance of the undelivered items is considered probable and substantially in the control of the company.  Arrangement consideration is allocated to units of accounting on a relative fair-value b asis or the residual method if the company is unable to determine the fair value of all deliverables in the arrangement.  Consideration allocated to a unit of accounting is limited to the amount that is not contingent upon future performance by the company.  Upon determination of separate units of accounting and allocated consideration, the general criteria for revenue recognition are applied to each unit of accounting.

Research and Development
 
Research and development costs are expensed as incurred.  These costs include, among other things, consulting fees and costs related to the conduct of human clinical trials.  We also allocate indirect costs, consisting primarily of operational costs for administering research and development activities, to research and development expenses.

Share-Based Compensation

In December 2004, the Financial Accounting Standards Board (“FASB”) issued amended guidance on accounting for “Stock Compensation”.  The amended guidance requires all share-based payments, including stock option grants to employees, to be recognized as an operating expense in the statement of operations.  The expense is recognized over the requisite service period based on fair values measured on the date of grant.  We adopted the amended guidance on Stock Compensation effective August 1, 2005 using the modified prospective method and, accordingly, prior period amounts have not been restated.  Under the modified prospective method, the fair value of all new stock options issued after July 31, 20 05 and the unamortized fair value of unvested outstanding stock options at August 1, 2005 are recognized as expense as services are rendered.

Contingencies
 
Liabilities for loss contingencies arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount of the liability can be reasonably estimated. Recoveries from other parties are recorded when realized.

Recently Issued Accounting Pronouncements

In June 2009, the Financial Accounting Standards Board issued the FASB Accounting Standards Codification (the “Codification”).  Effective July 1, 2009, the Codification became the single source of authoritative nongovernmental U.S. generally accepted accounting principles (GAAP), superseding existing rules and related literature issued by FASB, the American Institute of Certified Public Accountants (“AICPA”) and Emerging Issues Task Force (“EITF”).  The Codification also eliminates the previous U.S. GAAP hierarchy and establishes one level of authoritative GAAP.  Rules and interpretive releases of the SEC under authority of federal securities laws are also sources of authoritative GAAP for SEC registrants.  All other literature is considered non-authoritative.  The Codification, which has not changed GAAP, was effective for interim and annual periods ended after September 15, 2009.  We adopted the Codification for the quarter ended October 31, 2009.  Other than the manner in which accounting guidance is referenced, the adoption of the Codification had no impact on our financial statements.

 
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In December 2007, FASB issued new accounting guidance related to the accounting for business combinations and related disclosures.  This guidance establishes principles and requirements for how an acquirer recognizes and measures in its financial statements the identifiable assets acquired, the liabilities assumed, any noncontrolling interest in the acquiree, and any goodwill acquired in a business combination.  It also establishes disclosure requirements to enable the evaluation of the nature and financial effects of a business combination.  The guidance is to be applied prospectively to business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008.  We adopted this guidance, effective August 1, 2009, and it did not have any effect on our financial statements.

In February 2008, FASB issued amended guidance to delay the fair value measurement and expanded disclosures about fair value measurements for nonfinancial assets and nonfinancial liabilities, except for items that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually), until fiscal years beginning after November 15, 2008.  Effective August 1, 2009, we adopted the guidance related to fair value measurements for nonfinancial assets and nonfinancial liabilities and the adoption of such guidance did not have any effect on our financial statements. 

In June 2008, FASB issued guidance for determining whether an equity-linked financial instrument (or embedded feature) is indexed to an entity’s own stock, which would qualify as a scope exception to derivative classification under ASC Topic, “Derivatives and Hedging”.  The guidance is effective for fiscal years beginning after December 15, 2008 and early adoption for an existing instrument is not permitted.  The Company adopted this guidance, effective August 1, 2009.  The adoption had no impact on our previously accounted for equity-linked financial instruments that were considered to be indexed to its own equity.  Refer to Note 6 for the result of the adoption on the equity-linked instruments included within the Securities Purchase Agreement entered into o n October 19, 2009.

In August 2009, FASB issued amended guidance on the measurement of liabilities at fair value.  The guidance provides clarification that in circumstances in which a quoted market price in an active market for an identical liability is not available, the fair value of a liability be measured using one or more of the valuation techniques that uses the quoted price of an identical liability when traded as an asset or, if unavailable, quoted prices for similar liabilities or similar assets when traded as assets.  If none of this information is available, an entity should use a valuation technique in accordance with existing fair valuation principles.  This guidance is effective for the first reporting period (including interim periods) after issuance.  We adopted this guidance in t he quarter ended October 31, 2009.  The adoption had no impact on our financial statements.

In October 2009, FASB issued amended guidance for separating consideration in multiple-deliverable arrangements.  It eliminates the requirement under previous guidance that all undelivered elements have vendor-specific objective evidence (VSOE) or third-party evidence (TPE) of fair value before recognizing a portion of revenue related to the delivered items, and establishes that revenue be allocated to each element based on its relative selling price, as determined by VSOE, TPE, or the entity’s estimated selling price if neither of the aforementioned is available.  Additionally, the amended guidance eliminates the residual method of allocation and expands required disclosures about multiple-element revenue arrangements.  It will be effective prospectively for revenue arrangements entered into beginning January 1, 2011, with early adoption permitted.  We are currently evaluating the impact that the adoption of this guidance will have, if any, on our financial statements.

In January 2010, the FASB issued a new guidance, “Improving Disclosures about Fair Value Measurements” (ASU 2010-06).  This provision amends previous provisions that require reporting entities to make new disclosures about recurring and nonrecurring fair value measurements including the amounts of and reasons for significant transfers into and out of Level 1 and Level 2 fair value measurements and separate disclosure of purchases, sales, issuances, and settlements in the reconciliation of Level 3 fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years beginning after December 15, 2009, except for Level 3 reconciliation disclosures which are effective for fiscal years, and interim periods within those fiscal years beginning after Decemb er 15, 2010.  The adoption of this guidance did not have a material impact on our results of operations or financial condition.
 
 
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In April 2010, the FASB issued a new guidance “Revenue Recognition – Milestone Method”.  This provision provides guidance on the criteria that should be met for determining whether the milestone method of revenue recognition is appropriate.  A vendor can recognize consideration that is contingent upon achievement of a milestone in its entirety as revenue in the period in which the milestone is achieved only if the milestone meets all criteria to be considered substantive.  The following criteria must be met for a milestone to be considered substantive.  The consideration earned by achieving the milestone should 1) be commensurate with either the level of effort required to achieve the milestone or the enhancement of the value of the item delivered as a result of a spec ific outcome resulting from the vendor’s performance to achieve the milestone; 2) related solely to past performance; 3) be reasonable relative to all deliverables and payment terms in the arrangement.  No bifurcation of an individual milestone is allowed and there can be more than one milestone in an arrangement.  Accordingly, an arrangement may contain both substantive and non substantive milestones.  This guidance is effective on a prospective basis for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010.  The adoption of this guidance does not have a material impact on our financial statements.

ITEM 7A.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

As of July 31, 2010, we were exposed to market risks, primarily changes in U.S. interest rates. As of July 31, 2010, we held total cash and cash equivalents of approximately $0.3 million. All cash equivalents have a maturity less than 90 days. Declines in interest rates over time would reduce our interest income from our investments.

ITEM 8.   FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.

The response to this Item is submitted as a separate section of this report commencing on Page F-1.

ITEM 9.  CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.

There have been no changes in or disagreements with accountants on accounting or financial disclosures in the past two fiscal years.

On December 1, 1993, certain stockholders of Armus Harrison & Co., or AHC, terminated their association with AHC, or the AHC termination, and AHC ceased performing accounting and auditing services, except for limited accounting services to be performed on our behalf.  In June 1996, AHC dissolved and ceased all operations.  The report of J.H. Cohn LLP with respect to our financial statements from inception to July 31, 2008 is based on the report of KPMG LLP from August 1, 1992 to July 31, 2002 and of AHC for the period from inception to July 31, 1992, although AHC has not consented to the use of such report herein and will not be available to perform any subsequent review procedures with respect to such report.  Accordingly, investors will be barred from asserting claims against AHC under Section 18 of the Exchange Act on the basis of the use of such report in any annual report on Form 10-K into which such report is incorporated by reference.  In addition, in the event any persons seek to assert a claim against AHC for false or misleading financial statements and disclosures in documents previously filed by us, such claim will be adversely affected and possibly barred.  Furthermore, as a result of the lack of a consent from AHC to the use of its audit report herein, or to its incorporation by reference into an annual report on Form 10-K, our officers and directors will be unable to rely on the authority of AHC as experts in auditing and accounting in the event any claim is brought against such persons under Section 18 of the Exchange Act based on alleged false and misleading Financial Statements and disclosures attributable to AHC.  The discussion regarding certain effects of the AHC termination is not meant and should not be construed in any way as le gal advice to any party and any potential purchaser should consult with his, her or its own counsel with respect to the effect of the AHC termination on a potential investment in our common stock or otherwise.

 
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ITEM 9A.  CONTROLS AND PROCEDURES.

EVALUATION OF DISCLOSURE CONTROLS AND PROCEDURES

Disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act are controls and other procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer, and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

It should be noted that there are inherent limitations to the effectiveness of any system of disclosure controls and procedures.  These limitations include the possibility of human error, the circumvention or overriding of the controls and procedures and reasonable resource constrains.  In addition, the design of any system of control is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote.  Accordingly, our controls and procedures, by their nature, only provide reasonable assurance regarding achieving the management's control objectives.

As of the end of the period covered by this annual report on Form 10-K, we conducted an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures.  Based upon the foregoing evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC and was accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer , as appropriate to allow timely decisions regarding the required disclosures.

MANAGEMENT’S ANNUAL REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING

Our management is responsible for establishing and maintaining adequate internal control over financial reporting and for the assessment of the effectiveness of internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)).  Internal control over financial reporting is a process designed by, under the supervision of our principal executive and principal financial officers, or persons performing similar functions, and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the financial statements in accordance with GAAP.

Our internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of our assets; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of the financial statements in accordance with GAAP, and that our receipts and expenditures are being made only in accordance with the authorizations of our management and directors; and (3) provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

Our internal control over financial reporting is designed to provide reasonable, but not absolute, assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with GAAP.  There are inherent limitations to the effectiveness of any system of internal control over financial reporting.  These limitations include the possibility of human error, the circumvention or overriding of the system and reasonable resource constraints.  Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of complia nce with the policies or procedures may deteriorate.

 
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In connection with the preparation of our annual financial statements, management, including our Chief Executive Officer and Chief Financial Officer, has undertaken an assessment of the effectiveness of our internal control over financial reporting as of July 31, 2010, based on criteria established in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission.  Management’s assessment included an evaluation of the design of our internal control over financial reporting and testing of the operational effectiveness of those controls.

Based on this assessment, management has concluded that our internal controls over financial reporting were effective as of July 31, 2010, in that they ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (2) accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

This annual report does not include an attestation report of our independent registered public accounting firm regarding internal control over financial reporting.  Management’s report was not subject to attestation by our independent registered public accounting firm pursuant to the rules of the Securities and Exchange Commission that permit us to provide only management’s report in this annual report.

CHANGES IN INTERNAL CONTROLS OVER FINANCIAL REPORTING

There has been no change in the Company's internal control over financial reporting during the quarter ended July 31, 2010 that has materially affected, or is reasonably likely to materially affect, the Company's internal control over financial reporting.

ITEM 9B.  OTHER INFORMATION.

None.

PART III
 
ITEM 10.   DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.

Board of Directors
 
Name
 
Age
 
Director Since
 
Current Position With Company
 Charles Muniz
 
55
 
2009
 
 President, Chief Executive Officer, Chief Financial Officer and Director
 John P. Brancaccio
 
62
 
2004
 
 Director
 David Sidransky, M.D.
 
50
 
2004
 
 Chairman of the Board
 Paul M. Weiss, Ph.D.
 
52
 
2003
 
 Director

Executive Officers
 
Name
 
Age
 
Current Position With Company
 
Officer Since (1)
 Charles Muniz
 
55
 
President, Chief Executive Officer, Chief Financial Officer and Director
 
2009

 (1) Officers of Tamir hold office until their successors are elected and qualified or until their earlier removal, death or resignation.

 
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Business Experience of Directors and Executive Officers

The Company’s Directors and Executive Officers have provided the following information about their principal occupation, business experience and other matters.

Charles Muniz joined us on April 3, 2009 as our President, Chief Operating Officer and Chief Financial Officer and a member of our Board of Directors and entered into an employment agreement with us to serve as our President, Chief Executive Officer (“CEO”) and Chief Financial Officer on October 19, 2009.  From 2007 until he joined Tamir, Mr. Muniz was a consultant to a wide variety of clients focusing primarily on the strategic use of operations and technology.  Prior to consulting, he was President and Chief Executive Officer of Digital Creations Corp., a company he founded which sold high-end systems, work stations, peripherals, networking and software products, from 1989 to 2007.  Mr. Muniz attended Pace University in New York and majored in Business Administration.  Through his experience as our Chief Executive Officer as well as his history with our company, in connection with his service on our Board of Directors, Mr. Muniz provides critical insights into our challenges, opportunities and operations, reflecting his detailed knowledge of our company, employees, customers, technology and industry.
 
John P. Brancaccio joined the Board in January 2004.  Since April 2004, Mr. Brancaccio has been the chief financial officer of Accelerated Technologies, Inc., an incubator for venture backed medical device companies.  He also serves on the boards of Callisto Pharmaceuticals, Inc., Synergy Pharmaceuticals, Inc. and TrovaGene, Inc., all of which are publicly traded biopharmaceutical companies where he is chairman of their respective audit committees and a member of their respective compensation and nominating committees.  He was the secretary and treasurer of Memory Pharmaceuticals Corporation from December 2003 to March 2004 after serving in the capacity of their acting chief financial officer from May 2002 to December 2003.  Prior to Memory Pharmaceuticals, Mr. Brancaccio held the positions of chief financial officer and chief operating officer of Eline Group, a publicly traded entertainment and media company, where he oversaw the roll up of several related companies into the group and completed private equity financing placements.  Prior to joining Eline Group, he held a number of senior executive positions in public and private companies including Atlantic Pharmaceuticals, Zambon Corporation, Deven International and Health Learning Systems.  During his tenure with these companies he participated in initial public offerings and negotiation of licensing and development agreements within both the pharmaceutical and biotechnology industries.  He is a retired Certified Public Accountant and a graduate of Seton Hall University.  Because of his strong background of service on the boards of various biopharmaceutical and life sciences companies and his involvement in capital raising and strategic transactions in our industry, we b elieve that Mr. Brancaccio provides a unique perspective and useful insight to our board as we review our growth strategy and strategic initiatives.
 
David Sidransky, M.D., joined the Board in May 2004, was elected Chairman of the Board in January 2008 and is the Chairman of our Scientific Advisory Board.  Dr. Sidransky is a founder of several private biotechnology companies and has served on scientific advisory boards of numerous private and public companies, including Medimmune, Telik, Roche and Amgen.  He was formerly on the board of scientific counselors at the National Institute of Dental and Craniofacial Research (NIDCR) and a member of the Recombinant DNA advisory committee at the National Institute of Health NIH (RAC).  He served on the board of directors of ImClone Systems, Zila Inc, and Xenomics and is now chairman of the board of Champions Biotechnology Inc.  Dr. Sidransky is on numerous editorial boards and has served as senior editor of several cancer related journals.  Currently, Dr. Sidransky is the Director of the Head and Neck Cancer Research Division at Johns Hopkins University School of Medicine.  In addition, he is Professor of Oncology, Otolaryngology-Head and Neck Surgery, Cellular & Molecular Medicine, Urology, Genetics, and Pathology at John Hopkins University and Hospital.  Dr. Sidransky is certified in Internal Medicine and Medical Oncology by the American Board of Medicine.  He has over 400 peer-reviewed publications, has contributed more than 60 cancer reviews and chapters, and also has numerous issued biotechnology patents.  He has been the recipient of many awards and honors, including the 1997 Sarstedt International Prize from the German Society of Clinical Chemistry, the 1998 Alton Ochsner Award Relating Smoking and Health by the American College of Chest Physicians and the 2004 Hinda Rosenthal Award by the American Association of Cancer Research.  Dr. Sidransky received his B.A. from Brandeis University and his M.D. from the Baylor Coll ege of Medicine.  Because of his strong background of service on the boards of various biopharmaceutical and life sciences companies and his involvement in capital raising and strategic transactions in our industry, we believe that Dr. Sidransky provides a unique perspective and useful insight to our board as we review our growth strategy and strategic initiatives.

Paul Weiss, Ph.D., joined the Board in February 2003.  Since October 2007, Dr. Weiss has been a Managing Director at Venture Investors, LLC, a Madison, Wisconsin-based venture capital group focusing on early-stage life sciences companies.  Prior to joining Venture Investors, LLC, Dr. Weiss was President of the Gala Biotech business unit of Cardinal Health (now Catalent Pharma Solutions) from February 2002 until October 2007.  He had served as a director on Gala’s Board from 1998 to 2001, when he joined the management team as Senior Vice President of Business Development.  He later became President of Gala and remained so during the acquisition of Gala by Cardinal Health in 2003 and then the acquisition of Gala (and other Cardinal Health businesses) by The Blackstone Group in 2007.  Prior to joining Gala, from 1998 to 2001, Dr. Weiss was Vice President of Technology and Product Licensing at 3-Dimensional Pharmaceuticals (3DP), which went public in 2001 and was later acquired by Johnson & Johnson.  Prior to joining 3DP, Dr. Weiss was Director of Licensing for Wyeth Pharmaceuticals.  Dr. Weiss holds a Ph.D. in Biochemistry and an MBA from the University of Wisconsin-Madison and a B.Sc. in Biochemistry from the Carleton University Institute of Biochemistry in Ottawa, Ontario.  Because of his strong background of service on the boards of various biopharmaceutical and life sciences companies and his involvement in capital raising and strategic transactions in our industry, we believe that Dr. Weiss provides a unique perspective and useful insight to our board as we review our growth strategy and strategic initiatives.

 
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Family Relationships

There are no family relationships among any of the Company’s directors or executive officers.
 
Independent Directors
 
The Board has determined that the following directors are “independent” under Nasdaq Marketplace Rule 4200(a)(15):  John P. Brancaccio, David Sidransky, M.D. and Paul M. Weiss, Ph.D.  The Board has also determined that the following directors (who are members of the Audit Committee) are “independent” in accordance with Section 10A(m)(3) of the Exchange Act: John P. Brancaccio, David Sidransky, M.D. and Paul M. Weiss, Ph.D.

Board Committee Membership

The Board has standing Compensation, Corporate Governance and Nominating, Audit, Research and Clinical Oversight, and Commercial and Business Development Oversight Committees.  The current membership of the standing committees is set forth in the following table:

 
Name
Compensation Committee
Corporate Governance and Nominating Committee
Audit Committee
Research and Clinical Oversight Committee
Commercial and Business Development Oversight Committee
Charles Muniz
         
John P. Brancaccio
**
*
**
   
David Sidransky, M.D.
*
**
*
**
*
Paul M. Weiss, Ph.D.
*
*
*
*
**
____________________________
 
 
*    Member
 
**  Chair

Compensation Committee.  All of the members of Tamir’s Compensation Committee are considered “independent directors” in accordance with Nasdaq Marketplace Rule 4200(a)(15).  In fiscal year 2010, the Compensation Committee met twice.

On June 28, 2004, the Board adopted Tamir Biotechnology, Inc.’s Compensation Committee Charter, a copy of which is maintained on our website at www.tamirbio.com.  According to its charter, the Compensation Committee shall consist of at least three members, each of whom shall be non-employee directors who have been determined by the Board to meet the independence requirements of the Nasdaq Stock Market.

 
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The Compensation Committee Charter describes the primary functions of the Compensation Committee as follows:

 
·
Review and approve executive compensation on an annual basis, including the corporate goals and objectives to be used in evaluating the performance of the CEO and determining the CEO’s compensation;
 
·
Review trends in management compensation, oversee the development of new compensation plans and, when necessary, approve the revision of existing plans;
 
·
Oversee management’s decisions concerning compensation and performance for non-executive officers;
 
·
Review the Company’s incentive compensation and other share-based plans and recommend change to such plans to the Board as needed;
 
·
Administer stock plans and benefit programs and approve any amendments to existing plans;
 
·
Recommend director compensation;
 
·
Evaluate compliance with the Company’s compensation plans and policies; and
 
·
Review the compensation policy for all of Tamir’s employees.

Corporate Governance and Nominating Committee.  All of the members of Tamir’s Corporate Governance and Nominating Committee are considered “independent directors” in accordance with Nasdaq Marketplace Rule 4200(a)(15).  In fiscal year 2010, the Corporate Governance and Nominating Committee did not meet.

The Corporate Governance and Nominating Committee was formed by the Board for the purpose of considering future nominees to the Board.  On November 28, 2007, the Board adopted Tamir Biotechnology, Inc.’s Corporate Governance and Nominating Committee Charter, a copy of which is maintained on our website at www.tamirbio.com.  According to its charter, the Corporate Governance and Nominating Committee shall be comprised of at least three directors, each of whom shall meet the independence requirements of the Nasdaq Stock Market.  

The Corporate Governance and Nominating Committee Charter describes the primary functions of the Corporate Governance and Nominating Committee as follows:

 
·
Identify and evaluate individuals qualified to serve as members of the Board (including individuals nominated by stockholders in proposals made in writing to the Company’s Secretary that are timely received and that contain sufficient background information concerning the nominee to enable proper judgment to be made as to the nominee’s qualifications);
 
·
Recommend for the Board’s selection nominees for election as directors of the Company at the next annual or special meeting of stockholders at which directors are to be elected or to fill any vacancies then existing on the Board;
 
·
Cause to be prepared and recommend to the Board the adoption of corporate governance guidelines and from time to time, review and assess the guidelines and recommend changes for approval by the Board;
 
·
From time to time, review and assess the Code of Business Conduct and Ethics and recommend changes for approval by the Board;
 
·
Make recommendations to the Board regarding issues of management succession; and
 
·
Conduct annual reviews and assessments of the adequacy of the Corporate Governance and Nominating Committee Charter and recommend any proposed changes to the Board for approval.

Audit Committee.  All of the members of Tamir’s Audit Committee are considered “independent directors” in accordance with Nasdaq Marketplace Rule 4200(a)(15) and Section 10A(m)(3) of the Securities Exchange Act.  Tamir’s Board has determined that Mr. Brancaccio qualifies as an “audit committee financial expert” as defined by Item 407 of Regulation S-K.  In fiscal year 2010, the Audit Committee met four times.

On November 25, 2008, the Board adopted the Amended and Restated Audit Committee Charter, a copy of which is maintained on our website at www.tamirbio.com.  According to its charter, the Audit Committee shall be comprised of at least three directors, each of whom shall meet the independence requirements of the Nasdaq Stock Market and Section 10A(m)(3) of the Exchange Act, and each of whom shall not have participated in the preparation of the financial statements of the Company at any time during the past three years.  The Audit Committee’s purpose, duties and responsibilities under its charter include those specified in the listing standards of the Nasdaq Stock Exchange for audit committees.

 
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The Audit Committee Charter describes the primary functions of the Audit Committee as follows:

 
·
Appoint, evaluate and, as the Committee may deem appropriate, terminate and replace our independent registered public accounting firm;
 
·
Monitor the independence of our independent registered public accounting firm;
 
·
Determine the compensation to be paid to our independent registered public accounting firm;
 
·
Review with management and our independent registered public accounting firm the effect of regulatory and accounting initiatives as well as off-balance sheet structures on the Company’s financial statements;
 
·
Review the experience and qualifications of the Company’s senior finance executives as well as senior members of the independent registered public accounting firm team and the quality control procedures thereof;
 
·
Pre-approve all audit services and permitted non-audit services to be performed by our independent registered public accounting firm and establish policies and procedures for the engagement of our independent registered public accounting firm to provide permitted non-audit services;
 
·
Conduct annual reviews and assessments of the adequacy of the Audit Committee Charter and the continued independence of the independent registered public accounting firm and recommend any proposed changes to the Board for approval;
 
·
Advise the Board with respect to the Company’s policies and procedures regarding compliance with applicable laws and regulations and with the Company’s Code of Business Conduct and Ethics;
 
·
Review all related-party transactions for potential conflict of interest situations and approve such related-party transactions;
 
·
Establish procedures for the confidential and anonymous receipt, retention and treatment of complaints regarding the Company’s accounting, internal controls and auditing matters; and
 
·
Report to the Board on all of the foregoing matters.

Research and Clinical Oversight Committee. The Research and Clinical Oversight Committee (“Research Committee”) was established in February 2007 and is chaired by David Sidransky, M.D.  All of the members of Tamir’s Research Committee are considered “independent directors” in accordance with Nasdaq Marketplace Rule 4200(a)(15).

The primary function of the Research Committee is to work closely with management and the Scientific Advisory Board to provide support and direction to the Company’s research and development programs. The Research Committee functions as an advisory committee and does not hold formal committee meetings or take formal committee actions.

Commercial and Business Development Oversight Committee.  The Commercial and Business Development Oversight Committee (“Development Committee”) was established in February 2007 and is chaired by Paul Weiss, Ph.D.  All of the members of Tamir’s Development Committee are considered “independent directors” in accordance with Nasdaq Marketplace Rule 4200(a)(15).

The primary function of the Development Committee is to assist management in pursuing commercial and business development opportunities for the products currently in development.  The Development Committee functions as an advisory committee and does not hold formal committee meetings or take formal committee actions.

 
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Section 16(a) Beneficial Ownership Reporting Compliance

Based upon a review of filings with the SEC and written representations of certain reporting persons that no other reports were required, we believe that during fiscal year 2010 all of our directors, executive officers and beneficial owners of more than 10% of any class of equity securities complied on a timely basis with the reporting requirements of Section 16(a) of the Exchange Act, except for the Form 4 filed by Dr. Sidransky in May 2010, which was not timely filed.

Code of Ethics

Tamir has adopted a written Code of Business Conduct and Ethics (“Code of Ethics”) that applies to the Company’s principal executive officer, principal financial officer, principal accounting officer, and controller and to all its other employees.  These standards are a guide to help ensure that all our employees live up to our high ethical standards.  A copy of the Code of Ethics is maintained on our website at www.tamirbio.com.

We intend to post on our website, any amendment to or waiver from any provision in our Code of Ethics that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions, and that relates to any element of the standards enumerated in the rules of the SEC.

ITEM 11.  EXECUTIVE COMPENSATION.

COMPENSATION COMMITTEE INTERLOCKS AND INSIDER PARTICIPATION

During the fiscal year ended July 31, 2010, the members of the Board who served on the Compensation Committee were Messrs. John P. Brancaccio, Donald R. Conklin and Paul M. Weiss, Ph.D.  Mr. Conklin resigned from the Board on January 2, 2010.  As of July 31, 2010 all such directors were independent directors and have never been officers of Tamir.  As of the date of this annual report on Form 10-K, Mr. Brancaccio and Dr. Weiss are independent directors and have never been officers of Tamir.  During the fiscal year ended July 31, 2010, no executive officer of Tamir served on the compensation committee or board of directors of any other entity which had any executive officer who also served on the Compensation Committee or Board of Tamir.

COMPENSATION DISCUSSION AND ANALYSIS

Compensation Philosophy

Tamir’s compensation program is based on the philosophy that the interests of our employees should be closely aligned with those of our stockholders.  The Company’s compensation program is based on the following principles:

 
·
Compensation opportunities should attract the best talent, motivate individuals to perform at their highest levels, reward outstanding achievement and retain the leadership and skills necessary for building long-term stockholder value;
 
·
Compensation should include a bonus potential which is tied directly to operating objectives; and
 
·
Compensation should include a long-term incentive award generally in the form of stock option grants to increase ownership in the Company and encourage executives to manage from the perspective of owners of the Company.
 
The Compensation Committee believes that the compensation program for executive officers should reward the achievement of the short-term and long-term objectives of the Company, and that compensation should be related to the value created for its stockholders.  However, given the highly volatile nature of biotechnology company stocks it would be impracticable for the Company to tie executive compensation solely to stock performance.  In making its compensation decisions, the Compensation Committee generally reviews the progress made by the individual officer in attaining his or her individual performance goals and the progress made by the Company in its drug development programs, while keeping the Company’s stock performance in mind.  Generally, performance tied to the long-term objectives of the Company or the o verall business objectives of the Company are rewarded with equity compensation, whereas performance tied to short-term goals of the Company, or individual performance, is rewarded with cash compensation.  As different elements of the Company’s compensation have different underlying rationale and policy, determinations the Compensation Committee made with regard to one compensation element have not influenced decisions it made with respect to other compensation elements it contemplated or awarded.  For example, the factor that our CEO may receive a bonus if the performance objectives are satisfied and may receive additional value through his stock options if the Company’s stock performs well has not influenced the determination as to the base salary of our CEO.

 
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The Company’s compensation philosophy was last reviewed by the Board in May 2007, at which time two new compensation programs were approved by the Board, the Incentive Bonus Program and the Annual Milestones bonus program.  These two bonus programs were approved by the Board because they each met the Company’s desire to reward and encourage executive officers and employees for not only causing the Company to meet its primary objectives but also to meet certain short-term objectives within a timeline prescribed by management.  See “Incentive Compensation” below for details relating to these two programs.

Role of the Compensation Committee

The Compensation Committee currently consists of Messrs. John P. Brancaccio, Chairman, and Paul M. Weiss Ph.D. All committee members have been and currently are non-employee directors as defined under Rule 16b-3 of the Exchange Act and satisfy the director independence standards of the Nasdaq Stock Market and the definition of “outside director” under Section 162(m) of the Internal Revenue Code.  No special expertise in compensation matters is required for appointment to the Compensation Committee.

The Compensation Committee is responsible for all components of the Company’s executive compensation program and for administering all stock option plans including the 2004 Stock Incentive Plan, under which stock option grants may be made to executive officers.  On an annual basis, the Compensation Committee reviews and approves the corporate goals and objectives relevant to the compensation for the CEO and other executive officers, if any.  The Compensation Committee evaluates at least once a year, the CEO and executive officers’ performance in light of these established goals and objectives and based upon these evaluations will set the CEO’s and executive officers’ annual compensation, including salary, bonus, incentive and equity compensation.

Role of Consultants and Market Review

The Compensation Committee possesses the authority under its charter to hire advisors to provide it with information as needed in making compensation decisions.  The Compensation Committee did not use a compensation consultant for fiscal year 2010.

Role of Management

While the Compensation Committee determines overall compensation philosophy, it relies on the CEO and other executive officers, if any, to make recommendations in accordance with such compensation philosophy.  The Company’s CEO and CFO, if any, provide the Board and the Compensation Committee with feedback on the performance of the Company’s non-executive officers and make compensation recommendations to the Compensation Committee for its approval.  In 2010, the CEO attended the Compensation Committee’s meetings to provide his perspectives on competition in the industry and the needs of the business, information regarding the Company’s performance and other advice specific to their areas of expertise.  However, the CEO did not attend meetings where his compensatio n and/or performance was discussed.  Once a recommendation has been approved by the Compensation Committee, it is sent to the Board for ratification.  Upon ratification by the Board, the execution and administration of the recommendation may be delegated by the Compensation Committee to management as the Compensation Committee deems appropriate.
 
 
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Mr. Muniz has been our only executive since he joined the Company on April 3, 2009.  At the time he joined the Company, the Compensation Committee agreed to pay him a consulting fee of $3,500 per week plus cost of travel between his home state of Florida and our office in New Jersey.  On October 19, 2009, the Company entered into an Employment Agreement (the “Employment Agreement”) with Mr. Muniz to serve as the Company’s President, Chief Executive Officer and Chief Financial Officer.  Under his Employment Agreement, Mr. Muniz will receive an annual base salary of $300,000 plus cost of travel between his home state of Florida and our office in New Jersey.  and is entitled to receive cash incentive compensation or annual stock option awards as determined b y the Board or the Compensation Committee of the Board from time to time.  In addition, Mr. Muniz is entitled to participate in any and all employee benefit plans established and maintained by the Company for executive officers of the Company.  Pursuant to the Employment Agreement, Mr. Muniz received an option (the “Option”), granted under and in accordance with the Company’s 2004 Stock Incentive Plan, to purchase an aggregate of 500,000 shares of Common Stock exercisable for ten years from the date the Option is granted. The Option shall vest in equal amounts on each of the first, second and third year anniversary of the grant so long as Mr. Muniz remains employed by the Company. The exercise price of the Option equals the fair market value of the Common Stock on the date of grant.
 
The Employment Agreement continues in effect for two years following the date of the agreement and automatically renews for successive one-year periods, unless Mr. Muniz’s employment is terminated by him or by the Company. In the event that Mr. Muniz’s employment is terminated by the Company for any reason, then Mr. Muniz is entitled to receive his earned but unpaid base salary and incentive compensation, unpaid expense reimbursements, accrued but unused vacation and any vested benefits under any employee benefit plan of the Company. In the event that Mr. Muniz’s employment is terminated by the Company without “Cause” or by Mr. Muniz for “Good Reason” (as such terms are defined in the Employment Agreement), and provided Mr. Muniz executes a release in favor of the Company, then in addition to the above mentioned payments and benefits, Mr. Muniz is entitled to receive an amount equal to his then current annual base salary, payable in equal installments over 12 months in accordance with the Company’s payroll practice, and all medical and health benefits for 18 months following the termination date.  In addition, in the event Mr. Muniz’s employment is terminated without Cause or for Good Reason within 12 months following a Change in Control (as defined in the Employment Agreement), and provided Mr. Muniz executes a release in favor of the Company, in lieu of the severance described above, Mr. Muniz is entitled to receive a lump cash payment equal to his then current annual base salary, all medical and health benefits for 18 months following the termination date and full acceleration of vesting of all unvested stock options and other share-based awards.  Mr. Muniz’s Employment Agreement requires him to refrain from competing with the Company and from hiring our employees and soliciting our customers for a period of one year following the termination of his employment with the Company for any reason.  The Employment Agreement was filed as Exhibit 10.5 to the Company’s Form 8-K filed with the SEC on October 20, 2009.

Executive Compensation Components

Compensation for the Company’s executive officers includes the following components:

Base Salary.  Fixed annual compensation that is certain as to payment and provides continuous income to meet ongoing living costs.  This component is intended to ensure that Tamir is able to retain executives capable of achieving the Company’s strategic and business objectives.  The Compensation Committee reviews executive officers’ salaries annually and will make adjustments based on its expectations of that officer’s performance as compared to the officer’s actual performance and what the Compensation Committee’s expectations are for that officer’s future performance.  Additionally, the Compensation Committee factors in cost of living adjustments as well as the Company’s overall performance and stock performance.   As described on our annual report on Form 10-K for the fiscal year 2008, in 2008, the Compensation Committee also utilized a study of market compensation levels prepared by an independent compensation consultant in order to evaluate the executive’s compensation, including base salaries.  Such a study was used by the Compensation Committee in setting base salaries for the Company’s fiscal year 2008.  Such study was not used in previous years, except for fiscal year 2008 and was not used in fiscal year 2010.

In light on the Company’s financial difficulties, lack of executive leadership and inability to conduct a thorough market-based analysis of executive compensation, the Compensation Committee determined that Mr. Muniz, the Company’s sole executive officer, should receive the same base compensation package, in all material respects, as his predecessor, Kuslima Shogen.

 
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Stock Option Grants.  Long-term incentive plan which offers eligible Company officers and employees incentives to put forth maximum efforts for the success of the Company’s business, to afford executive officers an opportunity to acquire a proprietary interest in the Company and to relate the compensation of officers to the value they create for the Company’s stockholders.  Currently, all share-based awards are granted under the 2004 Stock Incentive Plan, which was approved by the Board of Directors and stockholders of the Company in November 2003 and in January 2004, respectively.  The 2004 Stock Incentive Plan provides for the grant of stock options and other share-based awards to employees, officers, consultants, ind ependent contractors and directors providing services to Tamir and its subsidiaries as determined by the Board or by the Compensation Committee.  The types of awards that may be granted under the 2004 Stock Incentive Plan are stock options, stock appreciation rights, restricted stock, restricted stock units, performance awards, dividend equivalents, other stock grants, other share-based awards and any combination thereof.  Stock options are granted based on the fair market value of a share on the date of grant of such option.  The terms, time and method of the options are determined at the sole discretion of the Compensation Committee.

At the time he joined the Company in April 2009, Mr. Muniz did not receive any share-based compensation.  After completion of the Company’s financing in October 2009, pursuant to his Employment Agreement, Mr. Muniz received stock options to purchase a total of 500,000 shares of Common Stock.  The Compensation Committee determined that this was an appropriate grant in light of prior grants made to the Company’s former CEO, Mr. Muniz’s success in obtaining financing for the Company in very difficult market conditions and the need to provide Mr. Muniz with additional incentive to create further value for the Company’s stockholders.

Incentive Compensation.  The primary purpose is to align the interests of the executive officers with those of the stockholders by rewarding executive officers for creating stockholder value over the long-term.  The 2004 Stock Incentive Plan provides for the award of stock options, stock appreciation rights, restricted stock, restricted stock units, performance awards, dividend equivalents, and other stock grants or stock based awards.

Other Benefits.  The CEO is eligible to participate in the Company’s 401(k) plan, health and dental coverage, life insurance, disability insurance, paid time off and paid holidays on the same terms as are available to all employees generally.  Other benefits which have previously been made available to the CEO, though not our current CEO, are the payment of reasonable costs of temporary housing, reasonable airfare associated with relocation and relocation assistance. We have previously provided the CEO with a monthly auto allowance and paid the premiums on a life insurance policy for the CEO where the Company was not the beneficiary of that life insurance policy, however, these benefits are not presently utilized by our current CEO. 60; These awards are designed to be competitive with overall market practices, and are in place to attract and retain the personnel needed in the business.

Post-termination Agreements.  Other than severance payments provided for in Mr. Muniz’s Employment Agreement and Ms. Shogen’s Retirement Agreement, as described in the annual report on Form 10-K/A filed with the SEC on November 30, 2009, the Company does not utilize post-termination agreements.  In addition, under grants awarded pursuant to the 2004 Stock Incentive Plan, the  recipients of such grants have received Stock Option Agreements which contain provisions that allow for the awarded options to become fully vested and immediately exercisable or exercisable during the six months following a change in control but in no event beyond the option period provided in the Stock Option Agreement; provided, however, that the terms of Mr. Muniz’s Employment Agreement, as described above, supersede the terms set forth in his Stock Option Agreement.  Per the Company’s standard Stock Option Agreement, a change in control is deemed to occur if (i) a person, as defined by Section 13(d) and 14(d) of the Exchange Act, becomes the beneficial owner, directly or indirectly, of securities representing 20% or more of the combined voting power of the Company’s then outstanding shares (except that ownership by the McCash Family Limited Partnership must be 50% to qualify as a change in control); (ii) during any 12 month period, the individuals who were, at the beginning of such period, a majority of the Board cease to be a majority of the Board; (iii) the Company’s stockholders approve a merger or consolidation with another corporation except where the Company remains in control after such merger or consolidation or where the merger or consolidation was effected to recapitalize the Company and no one person ac quired more than 50% of the combined voting power of the Company; or (iv) the stockholders of the Company approve a plan of complete liquidation or enter into an agreement for the sale or disposition of all or substantially all of the assets of the Company.
 
 
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Additionally, under the terms of the Stock Option Agreements issued under the 2004 Stock Incentive Plan, if there is a termination of service due to the death, total disability or retirement of the optionee on or after age 65 after seven years of service with the Company, then the options become fully exercisable at the time of death, total disability or retirement, as the case may be, and may be exercised by the optionee or optionee’s estate during the six months following the month of optionee’s death, total disability or retirement but in no event beyond the option period provided in the Stock Option Agreement.  If there is a termination of employment due to voluntary resignation then to the extent options are exercisable as of the date of the termination, such options may be exercised within six months of the date of termination of employment.  If there is termination for cause, then to the extent options are exercisable as of the date of the termination, such options may be exercised within 30 days of the date of termination.  “Cause” is defined as (i) frequent and unjustifiable absenteeism other than optionee’s illness or physical or mental disability; (ii) fraud or dishonesty materially injurious to the Company; (iii) gross or willful misconduct or willful neglect to act which is committed or omitted by optionee in bad faith; (iv) gross breach of optionee’s fiduciary duties which has a materially injurious effect on the Company; (v) optionee’s conviction as a felon; or (vi) optionee’s willful or continuous neglect or refusal to perform his or her duties.  If there is termination for any reason other than those described above, then to the extent options are exercisable as of the date of the termination, such options may be exe rcised within 12 months of the date of termination of employment.
 
Under grants awarded pursuant to the Company’s 1997 and 1993 Stock Option Plans, prior to a dissolution or liquidation of the Company or a merger or consolidation where the Company is not the surviving corporation, the optionee has the right to exercise all outstanding options.  If the optionee terminates employment, then to the extent options are exercisable as of the date of termination, such options may be exercised within 190 days of the date of termination of employment.  If the Board determines that the optionee engaged in activities or employment contrary to the best interest of the Company, then the Board can cancel the options within 190 days of the termination of employment.  If an optionee dies while still in service to the Company, then to the extent options are exercis able as of the date of death, such options may be exercised.
 
The rationale for the acceleration of the options under the 2004 Stock Incentive Plan, and the 1997 and 1993 Stock Option Plans upon a change in control of the Company is to ensure that officers are motivated to pursue creating or obtaining the maximum value for stockholders and to encourage officers to remain with the Company after a change in control has occurred.
 
Kuslima Shogen, the Company’s former CEO and scientific founder, retired on March 31, 2009.  On April 25, 2008, Tamir entered into a retirement agreement with Ms. Shogen which was filed as Exhibit 99.1 to the Company’s Form 8-K filed with the SEC on April 28, 2008 (the “Retirement Agreement”).  Under the terms of the Retirement Agreement, during the two year period commencing April 1, 2008, Ms. Shogen was entitled to receive periodic payments at the rate of $300,000 per year.  The options to purchase the Company’s common stock held by Ms. Shogen on the date of her retirement remained exercisable after Ms. Shogen’s retirement in accordance with their terms. No change was made to the terms of such existing options under the Retirement Agreement, except t he Compensation Committee of the Company’s Board of Directors amended the Company’s 1993 Stock Option Plan and 1997 Stock Option Plan to allow such options to be transferred by Ms. Shogen to members of her family. The Compensation Committee agreed to give Ms. Shogen the ability to transfer her existing options granted under the 2004 Stock Incentive Plan to members of her family.  If Ms. Shogen elects COBRA continuation coverage after her retirement date, the Company will pay for Ms. Shogen’s COBRA insurance continuation premiums until the earliest of the second anniversary of her retirement date and the date Ms. Shogen is no longer eligible for COBRA insurance overage under applicable law or the date on which Ms. Shogen becomes eligible for Medicare. In the event Ms. Shogen becomes ineligible for COBRA coverage under the Company’s insurance plans for any reason other than her death prior to the second anniversary of her retirement date, the Company will make a lump sum cash payment to Ms. Shogen equal to the amount of the premiums the Company would have had to pay to maintain Ms. Shogen’s coverage under the Company’s insurance plans had Ms. Shogen remained eligible for coverage under such plans for the period commencing on the date Ms. Shogen became ineligible for such coverage and ending on the second anniversary of her retirement date.

Pursuant to the terms of the Retirement Agreement, Ms. Shogen also agreed to terminate the Royalty Agreement dated July 24, 1991, as amended on April 16, 2001 by and between the Company and Ms. Shogen and filed as Exhibit 10.37 to the Company’s Form 10-Q filed with the SEC on March 12, 2007 (the “Royalty Agreement”). The terms of the Royalty Agreement are described in Note 12 to the Financial Statements on pages F-44 through F-45 of the Company’s Form 10-K for the fiscal year 2008. In exchange for termination of the Royalty Agreement, the Company agreed to make the following payments and awards to Ms. Shogen:
 
 
38

 
 
 
·
A lump sum payment of $500,000 made within ten business days of the date of the Retirement Agreement, from which Tamir was entitled to deduct the amount of the outstanding principal and accrued interest of $187,410 owed by Ms. Shogen to Tamir as of the date of the Retirement Agreement.
 
·
If the NDA for ONCONASE® for the treatment of malignant mesothelioma is approved by the FDA, Ms. Shogen would receive a one time payment equal to 5% of the initial milestone payment payable to the Company by Par Pharmaceutical Inc. (“Par”) pursuant to the License Agreement dated as of January 14, 2008 by and between the Company and Par (the “License Agreement”).
 
·
If the NDA for ONCONASE® for the treatment of malignant mesothelioma is approved by the FDA, Ms. Shogen would also receive a payment of $350,000 on each of the first and second anniversaries of the date of such approval for a total payment of $700,000.
 
·
An option (the “Option”) to purchase an aggregate of 1,000,000 shares of the Company’s common stock under the 2004 Stock Incentive Plan at an exercise price equal to the fair market value of the common stock as of the date of the Retirement Agreement as determined under such plan. The Option has a term of ten years and will become exercisable only upon the approval of the NDA for ONCONASE® for the treatment of malignant mesothelioma is approved by the FDA. As the result of the option to purchase 250,000 shares of common stock granted under the 2004 Stock Incentive Plan to Ms. Shogen on March 5, 2008 in connection with the Company’s execution of the License Agreement and in order to enable the Company to grant this Option to Ms. Shogen, the Board of Directors amended the annual award limitation for a partic ipant in the 2004 Stock Incentive Plan for 2008 as it relates to Ms. Shogen from 1,000,000 shares to 1,250,000 shares.
 
·
Payments equal to 15% of any royalties payable with respect to net sales which are received by Tamir pursuant to any and all license agreements entered into by Tamir for the marketing and distribution of ONCONASE® and any other products derived from amphibian source extract, produced either as a natural, synthesized, and/or genetically engineered drug which are covered by the claims of any issued patent owned or controlled by Tamir which is issued and valid as of December 31, 2007 (the “Licensed Products”) and 5% of net sales of Licensed Products which Tamir books on its financial statements but only to the extent that the aggregate annual net sales of Licensed Products upon which such royalty payments are received by Tamir and annual net sales of Licensed Products booked by Tamir when combined are in excess of $100 m illion in a year. In the event either or both of the aggregate annual net sales of Licensed Products upon which Tamir receives royalties and the annual net sales of Licensed Products which Tamir books on its financial statements are less than $100 million, but when combined such aggregate annual net sales exceed $100 million, the payments to be received by Ms. Shogen in that year will be paid with respect to the amount of such aggregate net sales that exceeds $100 million and pro rated between the 15% Ms. Shogen is entitled to receive on royalties received by Tamir and the 5% Ms. Shogen is entitled to receive on net sales booked by Tamir based upon the percentage of the total net sales of the Licensed Products that year represented by aggregate net sales upon which Tamir receives a royalty and the net sales booked by Tamir. Ms. Shogen’s rights to receive these payments shall terminate when all claims under the relevant patents which cover the Licensed Products have expired.

On September 14, 2009, the Company entered into an amendment (the “Amendment”) to the Retirement Agreement amending certain terms.  Under the Retirement Agreement, Ms. Shogen was entitled to receive periodic payments during the two year period commencing April 1, 2008 at the rate of $300,000 per year.  Pursuant to the Amendment, the periodic payments were reduced to $150,000 per year.  Under the Retirement Agreement, Ms. Shogen was entitled to receive continuing payments equal to 15% of any royalties received by Tamir pursuant to any and all license agreements entered into by Tamir for the marketing and distribution of Licensed Products. Under the Amendment, the amount of such royalties related to net sales of Licensed Products to be received by Ms. Shogen has been reduced to 5%.  Under the Retirement Agreement, Ms. Shogen was entitled to receive continuing payments equal to 5% of net sales of Licensed Products booked by Tamir on its financial statements.  Under the Amendment, the amount of net sales of License Products booked by Tamir to be received by Ms. Shogen has been reduced to 2% of net sales. Under the Amendment, in the event Tamir obtains marketing approval for ONCONASE® from the Food and Drug Administration or the European Medicines Agency, Ms. Shogen will be entitled to receive an additional payment equal to the difference between the periodic payments actually paid to Ms. Shogen during the two year period commencing April 1, 2008 and $600,000, the original aggregate amount of periodic payments to which Ms. Shogen was entitled under the Retirement Agreement.  Such additional payment may be made by Tamir, at its option, in cash, Tamir common stock or a comb ination of both.  Except as specifically amended in the Amendment, all terms and conditions of the Retirement Agreement remain in full force and effect.

 
39

 
 
The following table summarizes the estimated value of the stock options for each named executive officer derived from the terms of the 2004 Stock Incentive Plan, the 1997 Stock Option Plan and the 1993 Stock Option Plan assuming that a triggering event took place on the last business day of our most recently completed fiscal year, July 31, 2010 and that the price per share of our common stock is the closing market price as of that date.
 
Name
 
Death or Total Disability(1)
   
Voluntary Termination or Termination for Cause(1)
   
Change in Control(1)
 
Charles Muniz
  $0     0     $0  
____________________________
 
 
(1)
These amounts represent the aggregate in-the-money value of stock options which would become vested as a direct result of the termination event or change in control before the applicable stated vesting date. The stated vesting date is the date at which an award would have vested absent such termination event or change in control.  This calculation of value does not attribute any additional value to stock options based on their remaining terms and does not discount the value of awards based on the portion of the vesting period elapsed at the date of the termination event or change in control.  These amounts represent the intrinsic value of stock options, based on a closing stock price of $0.29 on July 31, 2010.

Pension Plans. The Company does not have pension plans for its employees, executive officers or directors.

Non-Qualified Deferred Compensation Plans.  The Company does not have non-qualified deferred compensation plans for its employees, executive officers or directors.

Tax and Accounting Considerations

Deductibility of Executive Compensation.  In making compensation decisions affecting the executive officers, the Compensation Committee considers the Company’s ability to deduct under applicable federal corporate income tax law compensation payments made to executives.  Specifically, the Compensation Committee considers the requirements and impact of Section 162(m) of the Internal Revenue Code, which generally disallows a tax deduction for annual compensation in excess of $1 million paid to our named executive officers.  Certain compensation that qualifies under applicable tax regulations as “performance-based” compensation is specifically exempted from this deduction rule.  The Compensation Committee ca nnot assure that it will be able to fully deduct all amounts of compensation paid to persons who are named executive officers in the future.  Further, because the Compensation Committee believes it is important to preserve flexibility in designing its compensation programs, it has not adopted a policy that all compensation must qualify as deductible under Section 162(m).  The cash compensation that the Company paid to each of its named executive officers during 2009 was below $1 million.  We believe that stock options granted to named executive officers under the 1997 Stock Option Plan and the 2004 Stock Incentive Program would qualify as “performance-based compensation” and therefore are Section 162(m) qualified.
 
Accounting for Share Based Compensation.  On August 1, 2005, the Company adopted the fair value recognition provisions of the Financial Accounting Standards Board (“FASB”) amended guidance on accounting for Stock Compensation, to account for all stock grants under all of its stock plans.
 
 
40

 

Summary Compensation Table
 
The following table provides a summary of cash and non-cash compensation for each of the last three fiscal years ended July 31, 2010 and 2009 with respect to the persons serving as Tamir’s Chief Executive Officer and the persons serving as Tamir’s only other executive officer, the Chief Financial Officer, during the year ended July 31, 2010 (“Named Executive Officers”).
 
Name and Principal Position
Year
Salary
($)
Bonus
($)
Stock Awards
($)(1)
Option Awards
($)(1)
Non-Equity Incentive Plan Compensation
Non-Qualified Deferred Compensation Earnings
($)
All Other Compensation(2)
Total ($)
Charles Muniz
2010
$275,038 (4)
-
-
$142,500
-
-
$23,521(5)
$441,059
President, Chief Executive Officer
and Chief Financial Officer(3)
2009
$87,500 (6)
-
-
-
-
-
$11,041(7)
$98,541
____________________________

(1)
These amounts represent the dollar amount recognized for financial statement reporting purposes the grant date fair value of stock options granted to the named executive officers in accordance with the FASB amended guidance on accounting for Stock Compensation.  The grant date fair value was estimated using the Black-Scholes stock option pricing model in accordance with the FASB amended guidance on accounting for Stock Compensation.  Pursuant to the SEC rules, the amounts exclude the impact of estimated forfeitures related to service-based vesting conditions.  Valuation assumptions used in the calculation are as disclosed in this annual report on Form 10-K for the year ended July 31, 2010.
(2)
Excludes perquisites and other personal benefits that in the aggregate do not exceed $10,000.  These amounts consist of Tamir’s annual contributions to a 401(k) plan unless otherwise noted.
(3)
Mr. Muniz was appointed as the Company’s President, Chief Operating Officer, Chief Financial Officer and director to the Board on April 3, 2009.
(4)
Mr. Muniz initially began consulting with the Company on February 9, 2009.  On April 3, 2009, Mr. Muniz was appointed as the Company’s President, Chief Operating Officer and Chief Financial Officer.  Given the Company’s difficult financial condition, Mr. Muniz continued to receive consulting payments from the date he first began consulting with the Company continuing through October 19, 2009.  These amounts represent consulting fee from August 1, 2009 to October 16, 2009 which amounted to $38,500 and his wages from October 19, 2009 to July 31, 2010 amounted to $236,538.
(5)
This amount consists of travel cost between Mr. Muniz’ home state of Florida and New Jersey totaling $9,550 and health insurance reimbursement of $13,971 for fiscal year 2010.
(6)
These amounts represent consulting fee from his first day of employment through July 31, 2009.
(7)
This amount consists of travel cost between Mr. Muniz’ home state of Florida and New Jersey for a period of six months totaling $5,218 and health insurance reimbursement of $5,823 for fiscal year 2009.
 
Grants of Plan-Based Awards in Fiscal Year 2010
 
The following table contains information concerning the grant of stock options under equity and non-equity incentive plans to the Named Executive Officers during the fiscal year ended July 31, 2010:
 
 
41

 
 
        Estimated Future Payouts Under Non-Equity Incentive Plan Awards   Estimated Future Payouts Under Equity Incentive Plan Awards   All Other Stock Awards: Number of Shares of Stock or Units
(#)
   All Other Option Awards: Number of Securities Underlying Options
(#)
  Exercise or Base Price of Option Awards ($/Sh)   Grant Date Fair Value of Stock and Option Awards(1)
 
Name
 
Grant
Date
  Threshold
($)
  Target
($)
  Maximum
($)
 
Award
Unit
  Threshold
($)
  Target
($)
  Maximum
($)
Charles Muniz
 
10/19/09
 
n/a
 
n/a
 
n/a
                     
500,000
 
$0.34
 
   $142,500
 
(1)
The grant date fair value was estimated using the Black-Scholes stock option pricing model in accordance with the FASB amended guidance on accounting for Stock Compensation.  Pursuant to the SEC rules, the amounts exclude the impact of estimated forfeitures related to service-based vesting conditions.  Valuation assumptions used in the calculation are as disclosed in this annual report on Form 10-K for the year ended July 31, 2010.
 
Outstanding Equity Awards at Fiscal Year-End

The following table sets forth the information with respect to the Named Executive Officers concerning the exercisable and unexercisable stock option awards held as of July 31, 2010(1):

Name
 
Number of Securities Underlying Unexercised Options (#) Exercisable
 
Number of Securities Underlying Unexercised Options (#) Unexercisable
 
Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options
(#)
 
Option Exercise Price
($)
 
Option Expiration Date
Charles Muniz
 
-
 
500,000
 
-
 
$0.34
 
10/19/19
____________________________
 
(1)
The Company does not have stock awards as part of its compensation program, therefore the columns entitled “Stock Awards” have been omitted from this table.

Option Exercises and Stocks Vested

The Named Executive Officers did not exercise options during fiscal year 2010 and the Company did not grant stock awards as part of its compensation program.

Non-Employee Directors’ Compensation

In February 2007, the Board adopted a non-employee director compensation policy whereby each member of the Board who was not an employee of Tamir will receive $15,000 per year in consideration of the member’s serving on the Board, payable in four equal quarterly installments.  This cash compensation ceased in January 2009.  In addition, each non-employee director will be granted an annual retainer of 20,000 options on the last trading day of December for each year under the 2004 Stock Incentive Plan.  The Chairman of the Board will receive an option bonus equal to the number of options received by the Chairman for his board and committee memberships.  Committee chairpersons receive 10,000 options for each committee chaired while each committee member receives 5,000 options for each committee on which he serves.  The exercise price of the options will be equal to the closing price of the Common Stock on the date of the grant.  The options will vest on the first anniversary of the date of the grant provided that the option holder remains a director as of such anniversary date and the options will terminate on the sixth anniversary of the date of the grant.

 
42

 
 
As described in the Form 8-K filed by the Company on October 20, 2009, the Company closed on a private placement of convertible promissory notes and warrants in which the Company received $3,250,000 in gross proceeds on October 19, 2009.  As a condition to the closing of such financing, each member of the Board other than David Sidransky, Chairman of the Board, and Mr. Muniz agreed to resign from the Board upon the request of Dr. Sidransky made at any time following the closing and prior to December 31, 2009.  In connection with such condition, the Board amended the vesting of the options granted on December 31, 2008 to non-employee directors, except for Dr. Sidransky, to be accelerated in full upon their resignation as requested by the Chairman of the Board.  Additionally, with the exce ption of Dr. Sidransky, the terms of the options granted to non-employee directors on February 8, 2007, December 31, 2007 and December 31, 2008 were amended to provide that if the non-employee director leaves the Board, the option will be exercisable for two years, instead of one year, from the date such non-employee director leaves the Board any time between October 19, 2009 and December 31, 2009.

Donald R. Conklin and Kuslima Shogen resigned from the Board following a written request from Dr. Sidransky on January 2, 2010 and January 29, 2010, respectively.  Stephen K. Carter, M.D did not stand for reelection at the Annual Meeting on April 27, 2010.

Under our director compensation policies, directors who also serve as executive officers do not receive additional compensation for their service on our Board.

The exercise price and vesting schedules for the regular and discretionary option grants described above are set forth in the table titled “Directors’ Stock Options” below.  The total compensation paid to independent directors for their service as directors of the Company for fiscal year 2010 is set forth in the table titled “Directors’ Compensation” below.

During the fiscal year ended July 31, 2010, the following independent or non-employee directors were compensated as follows for their service as directors of the Company:

Directors’ Stock Options

During the fiscal year ended July 31, 2010, the following independent or non-employee directors were granted options under Tamir’s 2004 Stock Incentive Plan as described above:
 
Name
Number of Options Granted
Exercise Price of Options Granted
John P. Brancaccio
125,000(1)(2)
$0.26
Stephen K. Carter, M.D.*
-
-
Donald R. Conklin+
-
-
Kuslima Shogen (3)
11,667(3)
$0.34
David Sidransky, M.D.
180,000(1)(4)
$0.26
Paul M. Weiss, Ph.D.
125,000(1)(5)
$0.26
____________________________
*
Did not stand for reelection at the Annual Meeting on April 27, 2010.
+
Resigned from the Board on January 2, 2010.
(1)
All the options listed here were granted on April 28, 2010 which will vest on December 31, 2010, provided that the option holder continuously remained a director until such time, and expire on December 31, 2015.  The exercise price of these options was the closing price of the Company’s Common Stock on the date of the grant.
(2)
Mr. Brancaccio’s options are the result of his serving on the as Chairman of the Audit and Compensation Committees.
 (3)
Ms. Shogen’s options are the result of her serving as a member of the Board after her retirement.   These options expire on Oct 19, 2014, vested immediately and the exercise price was the closing price of the Company’s Common Stock on the date of grant.  Ms. Shogen resigned on January 29, 2010.
(4)
Dr. Sidransky’s options are the result of his serving as Chairman of the Board, Chairman of the Corporate Governance and Nominating Committee, Chairman of the Research and Clinical Oversight Committee and a member of the Commercial and Business Development Oversight Committee.
(5)
Dr. Weiss’ options are the result of his serving on the Compensation Committee, the Corporate Governance and Nominating Committee, the Audit Committee, the Research and Clinical Oversight Committee.
 
 
43

 

Directors’ Compensation

During the fiscal year ended July 31, 2010, the following independent or non-employee directors were compensated as follows for their service as directors of the Company:

Name
Fees Earned or Paid in Cash
($)
Stock Awards(1)
($)
Option Awards(1)
($)
Non-Equity Incentive Plan Compensation
($)
Change in Pension Value and Nonqualified Deferred Compensation Earnings
($)
All Other Compensation
($)
Total
($)
John P. Brancaccio
$ 0
-
$24,875
-
-
-
$24,875
Stephen K. Carter, M.D.*
$ 0
-
-
-
-
-
-
Donald R. Conklin+
$ 0
-
-
-
-
-
-
Kuslima Shogen++
$ 0
-
$2,812
-
-
-
$2,812
David Sidransky, M.D.
$ 0
-
$35,820
-
-
-
$35,820
Paul Weiss, Ph.D.
$ 0
-
$24,875
-
-
-
$24,875
____________________________
 
* Did not stand for reelection at the Annual Meeting on April 27, 2010.
+ Resigned from the Board on January 2, 2010.
++ Resigned from the Board on January 29, 2010.
(1)
These amounts represent the dollar amount recognized for financial statement reporting purposes for the fair value of stock options granted to non-employee directors for fiscal year 2010.  The grant date fair value of the options was estimated using the Black-Scholes stock option pricing model in accordance with the FASB amended guidance on accounting for Stock Compensation.  Valuation assumptions used in the calculation are as disclosed in this annual report on Form 10-K for the year ended July 31, 2010.
 
Outstanding Equity Awards at Fiscal Year-End

The following table sets forth the information with respect to the independent or non-employee directors concerning exercisable and unexercisable stock options held as of July 31, 2010(1):
 
 
44

 
 
Name
Number of Securities Underlying Unexercised Options (#) Exercisable
Number of Securities Underlying Unexercised Options (#) Unexercisable
Option Exercise Price
($)
Option Expiration Date
John P. Brancaccio
20,000
-
$4.38
12/30/10
 
20,000
-
$1.89
12/30/11
 
20,000
-
$1.60
12/30/12
 
15,000
-
$1.49
02/08/13
 
35,000
-
$1.72
12/31/13
 
35,000
-
$0.24
12/31/14
 
-
125,000(2)
$0.26
12/31/15
Stephen K. Carter, M.D.*
20,000
-
$4.38
11/03/10
 
20,000
-
$1.89
11/03/10
 
20,000
-
$1.60
11/03/10
 
5,000
-
$1.49
04/27/12
 
25,000
-
$1.72
04/27/12
 
25,000
 
$0.24
04/27/12
Donald R. Conklin+
10,000
-
$1.49
01/02/12
 
30,000
-
$1.72
01/02/12
 
30,000
-
$0.24
01/02/12
Kuslima Shogen++
11,667
-
$0.34
10/19/14
 
-
1,000,000(3)
$2.00
04/25/18
David Sidransky, M.D.
20,000
-
$4.38
12/30/10
 
20,000
-
$1.89
12/30/11
 
20,000
-
$1.60
12/30/12
 
70,000
-
$1.49
02/08/13
 
90,000
-
$1.72
12/31/13
 
90,000
-
$0.24
12/31/14
   
180,000(2)
$0.26
12/31/15
Paul M. Weiss, Ph.D.
20,000
-
$4.38
12/30/10
 
20,000
-
$1.89
12/30/11
 
20,000
-
$1.60
12/30/12
 
30,000
-
$1.49
02/08/13
 
50,000
-
$1.72
12/31/13
 
50,000
 
$0.24
12/31/14
 
-
125,000(2)
$0.26
12/31/15
____________________________
*
Is not standing for reelection at the Annual Meeting.
+
Resigned from the Board on January 2, 2010.
++
Resigned from the Board on January 29, 2010.
(1)
The Company does not have stock awards as part of its compensation program, therefore the columns entitled “Stock Awards” have been omitted from this table.
(2)
These options will vest on December 31, 2010, provided that the option holder continuously remained a director as of December 31, 2010.
(3)
These performance options are only exercisable upon the meeting of the conditions set out in Ms. Shogen’s Retirement Agreement as previously described.
 
 
45

 
 
REPORT OF THE COMPENSATION COMMITTEE OF THE BOARD OF DIRECTORS

The Compensation Committee has overall responsibility for evaluating and approving the Company’s executive officer compensation plans, policies and programs, including compensation of the Chief Executive Officer.  During the fiscal year ended July 31, 2010 the Compensation Committee consisted of three independent directors.  Our compensation program, both for our executive officers as well as for all employees, is based on the philosophy that the interests of our employees should be closely aligned with those of our stockholders.  As with many other biotechnology companies, Tamir's current level of development and the highly volatile nature of biotechnology stocks in general makes executive compensation, which is normally based on sales and earnings goals, or strictly based on stoc k performance, impracticable.  In determining compensation, the Compensation Committee generally reviews the progress made by the individual officer in attaining his or her individual goals and the progress made by the Company in its drug development programs.  In addition, the Compensation Committee keeps the Company's stock performance in mind when making compensation decisions.  Finally, the Compensation Committee generally reviews and takes into account competitive factors regarding compensation.  Our compensation program is based on the following principles:
 
 
·
Compensation opportunities should attract the best talent, motivate individuals to perform at their highest levels, reward outstanding achievement, and retain the leadership and skills necessary for building long-term stockholder value;
 
·
Compensation should include a bonus potential which is tied directly to operating objectives; and
 
·
Compensation should include a long-term incentive award generally in the form of stock option grants to increase ownership in the Company and encourage executives to manage from the perspective of owners of the Company.

The Compensation Committee has reviewed and discussed the Compensation Discussion and Analysis as required by Item 402(b) of Regulation S-K with management.  Based on these reviews and discussions, the Compensation Committee recommended to the Board of Directors that the Compensation Discussion and Analysis be included in the Company’s annual meeting proxy statement on Schedule 14A.
 
This report is respectfully submitted by the members of the Compensation Committee of the Board.
 
   
John P. Brancaccio, Chairman
 
    David Sidransky, M.D.  
   
Paul M. Weiss, Ph.D.
 
 
ITEM 12.   SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.

Security Ownership of Certain Beneficial Owners
 
Name and address of beneficial
owner or identity of group
 
Amount and Nature of Beneficial Ownership
 
Percent of shares outstanding(1)
         
Charles Muniz(2)
c/o Tamir Biotechnology, Inc.
300 Atrium Drive
Somerset, NJ 08873
 
20,609,998(3)
 
30.6%
Knoll Capital Management LP, Fred Knoll and Europa International, Inc. (4)
666 Fifth Avenue, Suite 3702
New York, NY 10103
 
18,280,520(5)
 
29.1%
McCash Family Limited Partnership
N3810 S. Grand Oak Drive
Iron Mountain, MI 49801
 
3,421,452(6)
 
 
7.2%
 
James O. McCash, and the James O. McCash Trust
N3820 S. Grand Oak Drive
Iron Mountain, MI 49801
 
2,910,820(7)
 
6.1%
____________________________
 
 
46

 
 
(1)
The percentage of stock outstanding for each stockholder is calculated by dividing (i) the number of shares deemed to be beneficially held by such stockholder as of the date of the calculation by (ii) the sum of (A) the number of shares of Common Stock outstanding as of the date of the calculation, plus (B) the number of shares issuable upon conversion of securities convertible into shares of Common Stock and upon exercise of options or warrants held by such stockholder which were convertible or exercisable as of the date of the calculation or which will become exercisable within 60 days after the date of the calculation.
(2)
Mr. Muniz is the Company’s President, Chief Executive Officer, Chief Financial Officer and a Director.
(3)
Includes 300,000 shares of Common Stock owned by Mr. Muniz’ wife and 19,999,998 shares subject to a convertible note and warrants which are currently convertible or exercisable or which will become convertible or exercisable within 60 days after July 31, 2010.
(4)
Knoll Capital Management LP, Fred Knoll and Europa International, Inc. filed a Schedule 13D on December 7, 2009 with the Securities and Exchange Commission (the “SEC”) as joint filers.
(5)
Includes 15,214,286 shares subject to a convertible note and warrants which are currently convertible or exercisable or will become convertible or exercisable within 60 days of July 31, 2010 held by Europa International Inc. and 214,286 shares subject to warrants which are currently exercisable or will become exercisable within 60 days of July 31, 2010 held by Knoll Special Opportunities Fund II Master Fund Ltd.  This information concerning the stock ownership of Knoll Capital Management LP, Fred Knoll and Europa International, Inc. was obtained from the Schedule 13D filed by them with the SEC on December 7, 2009 and other information known to the Company.
(6)
This information concerning the stock ownership of the McCash Family Limited Partnership was obtained from the Schedule 13D/A filed with the SEC on January 8, 2007 and other information known to the Company.
(7)
This information concerning the stock ownership of the James O. McCash, and the James O. McCash Trust was obtained from the Schedule 13G/A filed with the SEC on February 5, 2008 and other information known to the Company.

Security Ownership of Management

Security Ownership of Management
 
Name and address of beneficial
owner or identity of group(1)
 
Position
 
Amount and Nature of Beneficial Ownership(2)
 
Percent of shares
outstanding(3)
Charles Muniz
 
President, Chief Executive Officer, Chief Financial Officer and Director
 
20,609,998(4)
 
30.6%
John P. Brancaccio
 
Director
 
151,300(5)
 
*
David Sidransky, M.D.
 
Chairman of the Board
 
355,000(6)
 
*
Paul M. Weiss, Ph.D.
 
Director
 
230,090(7)
 
*
All Named Executive Officers and directors as a group (4 persons)
     
21,346,388(8)
 
31.4%
____________________________
 
*
Represents less than 1% of Tamir’s outstanding Common Stock.
(1)
Unless otherwise indicated below, the persons in the above table have sole voting and investment power with respect to all shares beneficially owned by them.  The address of all Named Executive Officers and directors is c/o Tamir Biotechnology, Inc., 300 Atrium Drive, Somerset, New Jersey, 08873.
(2)
All shares listed are Common Stock.  Except as discussed below, none of these shares are subject to rights to acquire beneficial ownership, as specified in Rule 13d-3(1) under the Exchange Act, and the beneficial owner has sole voting and investment power, subject to community property law where applicable.
(3)
The percentage of stock outstanding for each stockholder is calculated by dividing (i) the number of shares deemed to be beneficially held by such stockholder as of July 31, 2010 by (ii) the sum of (A) the number of shares of Common Stock outstanding as of July 31, 2010 plus (B) the number of shares issuable upon exercise of options or warrants held by such stockholder which were exercisable as of July 31, 2010 or which will become exercisable within 60 days after July 31, 2010.
 
 
47

 
 
(4)
Includes 300,000 shares of Common Stock owned by Mr. Muniz’ wife and 19,999,998 shares subject to a convertible note and warrants which are currently convertible or exercisable or which will become convertible or exercisable within 60 days after July 31, 2010.
(5)
Includes 145,000 shares underlying options which are currently exercisable or which will become exercisable within 60 days after July 31, 2010.
(6)
Includes 310,000 shares underlying options which are currently exercisable or which will become exercisable within 60 days after July 31, 2010.
(7)
Includes 6,535 shares of Common Stock owned by Mr. Weiss’ wife and 190,000 shares underlying options which are currently exercisable or which will become exercisable within 60 days after July 31, 2010.
(8)
Includes all shares owned beneficially by the directors and the executive officers named in the table.

The following table provides information as of July 31, 2010 on our equity based compensation plans that may be issued upon the exercise of stock options:

Plan Category
 
Number of securities to be issued upon exercise of outstanding options, warrants and rights
 
Weighted-average exercise price of outstanding options, warrants and rights
 
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
   
(a)
 
(b)
 
(c)
Equity compensation plans approved by security holders
 
3,535,467
 
$ 1.45
 
5,175,333

ITEM 13.  CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE.

Related Party Transactions

The Company recognizes that related party transactions can create the appearance that Company decisions are made based on factors other than the Company’s best interest or the best interest of the Company’s stockholders.  Related party transactions can also create potential or actual conflicts of interest between the Company and the related party.  For purposes of Item 404 of Regulation S-K, related person transactions are transactions which exceed $120,000 in the aggregate or 1% of the average of the Company’s total assets at year end for the last three completed fiscal years, to which the Company and a related party with a direct or indirect material interest, participated.  The Company’s Code of Business Conduct and Ethics requires that any such related party t ransactions be specifically approved by the Audit Committee.  In addition directors, officers and employees must notify the Ethics Officer or the Chair of the Audit Committee of the existence of any actual or potential conflicts of interest.  The Audit Committee performs a review of related party transactions as part of its review of the annual report on Form 10-K for the fiscal year ended July 31, 2010.

The Company was a party to the following transactions in which the amount involved exceeded $120,000 and in which any executive officers, directors, holders of more than 5% of our capital stock and members of such person’s immediate families had or will have a direct or indirect material interest.

On October 20, 2009, the Company completed a sale of 65 units (the “Units”) in a private placement (the “Offering”) to certain investors pursuant to a securities purchase agreement entered into on October 19, 2009.  Each Unit consists of (i) $50,000 principal amount of 5% Senior Secured Convertible Promissory Notes (collectively, the “Notes”) convertible into shares of the Company’s Common Stock, (ii) Series A Common Stock Purchase Warrants (the “Series A Warrants”) to purchase in the aggregate that number of shares of Common Stock initially issuable upon conversion of the aggregate amount of Notes issued as part of the Unit, at an exercise price of $0.15 per share with a three year term and (iii) Series B Common Stock Purchase W arrants (the “Series B Warrants” and together with the Series A Warrants, the “Warrants”) to purchase in the aggregate that number of shares of Common Stock initially issuable upon conversion of the aggregate amount of Notes issued as part of the Unit, at an exercise price of $0.25 per share with a five year term. The closing of the Offering occurred on October 19, 2009 and the Company received an aggregate of $3,250,000 in gross proceeds.  Charles Muniz, the Company’s President, Chief Executive Officer, Chief Financial Officer and director, subscribed for 20 Units, certain trusts and individuals related to James O. McCash, a beneficial owner of more than five percent of the Company’s voting securities, subscribed for an aggregate of 20 Units, Europa International Inc., an affiliate of Knoll Capital Management LP, a beneficial owner of more than five percent of the Company’s voting securities, subscribed for 15 Units.  The relevant documentat ion and additional description of the Offering were filed with the SEC on Form 8-K on October 20, 2009.  The Company’s entry into an employment agreement with Mr. Muniz upon terms reasonably acceptable to the investors in the Offering was a condition to the Closing.

 
48

 
 
In addition, see the discussion of the Retirement Agreement and arrangements related thereto by and between the Company and the Company’s CEO, Kuslima Shogen, set forth above in the Post-Termination Agreement subsection of the “Compensation and Discussion Analysis”.  

In December 2009, the Company engaged Champions Biotechnology, Inc. to provide certain services for approximately $99,900.  The Company’s non-executive Chairman of the Board of Directors, Dr. David Sidransky, is also the chairman of the board of directors as well as a principal stockholder of Champions Biotechnology, Inc.  As of July 31, 2010, the agreed amount was paid in full.

Director Independence

Please see the sections entitled Independent Directors and Board Committee Membership in Item 10 “Directors, Executive Officers and Corporate Governance” above for disclosures on Board independence and committee membership.

ITEM 14.  PRINCIPAL ACCOUNTING FEES AND SERVICES.

In accordance with the requirements of the Sarbanes-Oxley Act of 2002 and the Audit Committee Charter, all audit and audit-related work and all non-audit work performed by the independent registered public accounting firm, J.H. Cohn LLP, is approved in advance by the Audit Committee, including the proposed fees for such work.  The Audit Committee is informed of each service actually rendered that was approved through its pre-approval process.

Audit Fees

Audit fees paid by Tamir to J.H. Cohn LLP for the audit of the financial statements included in Tamir’s annual report on Form 10-K, auditors’ review of the financial statements included in Tamir’s Quarterly Reports on Form 10-Q, work related to Tamir’s registration statements and consultation on accounting topics for the years ended July 31, 2010 and 2009 totaled approximately $124,000 and $101,000, respectively.

Audit-Related Fees

None.
 
 
49

 

Tax Fees

None.

All Other Fees

None.
 
PART IV
 
ITEM 15.  EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
 
(a)(1) and (2)   The response to these portions of Item 15 is submitted as a separate section of this report commencing on page F-1.    
(a)(3)   Exhibits (numbered in accordance with Item 601 of Regulation S-K).    
         
Exhibit No.
 
Item Title
 
Filed Herewith or Incorporated by Reference
         
3.1
 
Certificate of Incorporation, dated June 12, 1981 (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form S-1, File No. 333-112865, filed on February 17, 2004)
 
*
3.2
 
Amendment to Certificate of Incorporation, dated February 18, 1994 (incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form S-1, File No. 333-112865, filed on February 17, 2004)
 
*
3.3
 
Amendment to Certificate of Incorporation, dated December 26, 1997 (incorporated by reference to Exhibit 3.3 to the Company’s Registration Statement on Form S-1, File No. 333-112865, filed on February 17, 2004)
 
*
3.4
 
Amendment to Certificate of Incorporation, dated January 14, 2004 (incorporated by reference to Exhibit 3.4 to the Company’s Registration Statement on Form S-1, File No. 333-112865, filed on February 17, 2004)
 
*
3.5
 
Certificate of Designation for Series A Preferred Stock, dated September 2, 2003 (incorporated by reference to Exhibit 3.5 to the Company’s Registration Statement on Form S-1, File No. 333-112865, filed on February 17, 2004)
 
*
3.6
 
Certificate of Elimination of Series A Preferred Stock, dated February 3, 2004 (incorporated by reference to Exhibit 3.6 to the Company’s Registration Statement on Form S-1, File No. 333-112865, filed on February 17, 2004)
 
*
3.7
 
Certificate of Amendment to Certificate of Incorporation, dated April 27, 2010 (incorporated by reference to Exhibit 3.1 to the Company's Current Report on Form 8-K, filed on April 30, 2010)
 
*
3.8
 
By-Laws (incorporated by reference to Exhibit 3.4 to Registration Statement on Form S-1, File No. 333-111101, filed on December 11, 2003)
 
*
4.1
 
Form of Note
 
*
4.2
 
Form of Series A Common Stock Purchase Warrant
 
*
4.3
 
Form of Series B Common Stock Purchase Warrant
 
*
10.1
 
1993 Stock Option Plan and Form of Option Agreement (incorporated by reference to Exhibit 10.10 to Registration Statement on Form SB-2, File No. 33-76950, filed on August 1, 1994)
 
*
10.2
 
1997 Stock Option Plan (incorporated by reference to Exhibit 10.2 to Registration Statement on Form S-1, File No. 333-111101, filed on December 11, 2003)
 
*
 
 
50

 
 
Exhibit No.
  Item Title   Filed Herewith or Incorporated by Reference
         
10.2.1
 
Amendment No. 1 to 1997 Stock Option Plan (incorporated by reference to Exhibit 10.2.1 to the Company’s Quarterly Report on Form 10-Q, filed on June 9, 2008)
 
*
10.3
 
2004 Stock Incentive Plan (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-1, File No. 333-112865, filed on February 17, 2004)
 
*
10.3.1
 
Amendment No. 1 to 2004 Stock Incentive Plan (incorporated by reference to Exhibit 10.3.1 to the Company’s Quarterly Report on Form 10-Q, filed on June 9, 2008)
 
*
10.4
 
Form of Subscription Agreement and Warrant Agreement used in Private Placements completed in February 2000 (incorporated by reference to Exhibit 10.21 to the Company’s annual report on Form 10-K, filed on October 30, 2000)
 
*
10.5
 
Form of Subscription Agreement and Warrant Agreement used in the August and September 2000 Private Placements (incorporated by reference to Exhibit 10.24 to the Company’s Quarterly Report on Form 10-Q, filed on December 15, 2000)
 
*
10.6
 
Form of Subscription Agreement and Warrant Agreement used in the April 2001 Private Placements (incorporated by reference to Exhibit 10.23 to Registration Statement on Form S-1, File No. 333-38136, filed on July 30, 2001)
 
*
10.7
 
Form of Convertible Note entered into in April 2001 (incorporated by reference to Exhibit 10.24 to Registration Statement on Form S-1, File No. 333-38136, filed on July 30, 2001)
 
*
10.8
 
Form of Subscription Agreement and Warrant Agreement used in the July 2001 Private Placements (incorporated by reference to Exhibit 10.25 to Registration Statement on Form S-1, File No. 333-38136, filed on July 30, 2001)
 
*
10.9
 
Form of Subscription Agreement and Warrant Agreement used in the August and October 2001 private placement (incorporated by reference to Exhibit 10.26 to Registration Statement on Form S-1, File No. 333-38136, filed on December 14, 2001)
 
*
10.10
 
Form of Subscription Agreement and Warrant Agreement used in the September 2001, November 2001 and January 2002 private placements (incorporated by reference to Exhibit 10.27 to Registration Statement on Form S-1, File No. 333-38136, filed on February 21, 2002)
 
*
10.11
 
Warrant issued in the February 2002 private placement (incorporated by reference to Exhibit 10.28 to Registration Statement on Form S-1, File No. 333-38136, filed on February 21, 2002)
 
*
10.12
 
Form of Subscription Agreement and Warrant Agreement used in the March 2002, April 2002 and May 2002 private placements (incorporated by reference to Exhibit 10.29 to Registration Statement on Form S-1, File No. 333-89166, filed on May 24, 2002)
 
*
10.13
 
Form of Subscription Agreement and Warrant Agreement used in the June 2002 and October 2002 private placements (incorporated by reference to Exhibit 10.30 to the Post-Effective Amendment to Registration Statement on Form S-1, File No. 333-38136, filed on March 3, 2003)
 
*
10.14
 
Form of Note Payable and Warrant Certificate entered into April, June, July, September, November and December 2002 (incorporated by reference to Exhibit 10.31 to the Post-Effective Amendment to Registration Statement on Form S-1, File No. 333-38136, filed on March 3, 2003)
 
*
10.15
 
Form of Note Payable and Warrant Certificate entered into November 2001, January, March and May 2003 (incorporated by reference to Exhibit 10.23 to the Company’s annual report on Form 10-K, filed on October 29, 2003)
 
*
10.16
 
Form of Subscription Agreement and Warrant Agreement used in the February 2003 and April through August 2003 private placements (incorporated by reference to Exhibit 10.24 to the Company’s annual report on Form 10-K, filed on October 29, 2003)
 
*
 
 
51

 
 
 
Exhibit No.
  Item Title   Filed Herewith or Incorporated by Reference
 
10.17
 
Form of Amended Notes Payable which amends the November 2001, April 2002, June 2002, July 2002, September 2002, November 2002 December 2002, January 2003, March 2003 and May 2003 notes payable (incorporated by reference to Exhibit 10.27 to The Company’s annual report on Form 10-K, filed on October 29, 2003)
 
*
10.18
 
Securities Purchase Agreement and Warrant Agreement used in September 2003 private placement and Form of Warrant Certificate issued on January 16, 2004 and January 29, 2004 to SF Capital Partners Ltd. (incorporated by reference to Exhibit 10.25 to the Company’s annual report on Form 10-K, filed on October 29, 2003)
 
*
10.19
 
Registration Rights Agreement used in September 2003 private placement with SF Capital Partners Ltd. (incorporated by reference to Exhibit 10.26 to the Company’s annual report on Form 10-K, filed on October 29, 2003)
 
*
10.20
 
Form of Securities Purchase Agreement used in May 2004 private placement with Knoll Capital Fund II, Europa International, Inc. and Clifford and Phyllis Kalista JTWROS (incorporated by reference to Exhibit 4.3 to Registration Statement on Form S-1, File No. 333-112865, filed on May 18, 2004)
 
*
10.21
 
Form of Registration Rights Agreement used in May 2004 private placement with Knoll Capital Fund II, Europa International, Inc. and Clifford and Phyllis Kalista JTWROS (incorporated by reference to Exhibit 4.4 to Registration Statement on Form S-1, File No. 333-112865, filed on May 18, 2004)
 
*
10.22
 
Form of Warrant Certificate issued on May 11, 2004 to Knoll Capital Fund II, Europa International, Inc. and Clifford and Phyllis Kalista JTWROS (incorporated by reference to Exhibit 4.5 to Registration Statement on Form S-1, File No. 333-112865, filed on May 18, 2004)
 
*
10.23
 
Form of Stock Option Agreement issued to the Company’s Board of Directors under the Company’s 1997 Stock Option Plan (incorporated by reference to Exhibit 10.23 to the Company’s quarterly report on Form 10-Q filed on June 9, 2005)
 
*
10.24
 
Form of Stock Option Agreement issued to the Company’s Executive Officers under the Company’s 1997 Stock Option Plan (incorporated by reference to Exhibit 10.24 to the Company’s quarterly report on Form 10-Q filed on June 9, 2005)
 
*
10.25
 
Separation Agreement and General Release with Andrew Savadelis dated May 26, 2005 (incorporated by reference to Exhibit 10.25 to the Company’s annual report on Form 10-K, filed on October 15, 2005)
 
*
10.26
 
Securities Purchase Agreement used in May 2005 private placement with Jeffrey D’Onofrio dated May 1, 2006 (incorporated by reference to Exhibit 10.26 to the Company’s annual report on Form 10-K, filed on October 16, 2006)
 
*
10.27
 
Form of Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed on July 19, 2006)
 
*
10.28
 
Registration Rights Agreement dated July 17, 2006 (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed on July 19, 2006)
 
*
10.29
 
Agreement to Amend Knoll Warrant dated July 17, 2006 (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K, filed on July 19, 2006)
 
*
10.30
 
Form of Amended Knoll Warrant (incorporated by reference to Exhibit 4.4 to the Company’s Current Report on Form 8-K, filed on July 19, 2006)
 
*
10.31
 
Agreement to Amend SF Capital Warrant dated July 17, 2006 (incorporated by reference to Exhibit 4.5 to the Company’s Current Report on Form 8-K, filed on July 19, 2006)
 
*
10.32
 
Form of Amended Warrant for SF Capital Partners, Ltd. (incorporated by reference to Exhibit 4.6 to the Company’s Current Report on Form 8-K, filed on July 19, 2006)
 
*
10.33
 
Securities Purchase Agreement dated July 17, 2006 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed on July 19, 2006)
 
*
 
 
52

 
 
Exhibit No.
  Item Title   Filed Herewith or Incorporated by Reference
         
10.34
 
Form of Stock Option Agreement for Executive Officers under the Company's 2004 Stock Incentive Plan (incorporated by reference to Exhibit 10.34 to the Company’s Quarterly Report on Form 10-Q, filed on March 12, 2007)
 
*
10.35
 
Offer letter agreement with Lawrence A. Kenyon dated January 16, 2007 (incorporated by reference to Exhibit 10.35 to the Company’s Quarterly Report on Form 10-Q, filed on March 12, 2007)
 
*
10.36
 
Summary of the Company's Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 10.36 to the Company’s Quarterly Report on Form 10-Q, filed on March 12, 2007)
 
*
10.37
 
Royalty Agreement between the Company and Kuslima Shogen, dated July 24, 1991 and Amendment to Royalty Agreement, dated April 16, 2001  (incorporated by reference to Exhibit 10.37 to the Company’s Quarterly Report on Form 10-Q, filed on March 12, 2007)
 
*
10.38
 
Office Lease Agreement, dated March 14, 2007, between I&G Garden State, LLC and the Company (incorporated by reference to Exhibit 10.38 to the Company’s Quarterly Report on Form 10-Q, filed on June 18, 2007)
 
 
*
10.39
 
Form of Distribution and Marketing Agreement, dated July 25, 2007, between the Company and USP Pharma Spolka Z.O.O. (incorporated by reference to Exhibit 10.39 to the Company’s Quarterly Report on Form 10-Q, filed on October 15, 2007)
 
 
*^
10.40
 
Form of Securities Purchase Agreement, dated July 25, 2007, between the Company and Unilab LP. (incorporated by reference to Exhibit 10.40 to the Company’s Quarterly Report on Form 10-Q, filed on October 15, 2007)
 
 
*
10.41
 
License Agreement, dated January 14, 2008, between the Company and Par Pharmaceutical, Inc. (incorporated by reference to Exhibit 10.41 to the Company’s Quarterly Report on Form 10-Q, filed on March 7, 2008)
 
 
*^
10.42
 
Supply Agreement, dated January 14, 2008, between the Company and Par Pharmaceutical, Inc. (incorporated by reference to Exhibit 10.42 to the Company’s Quarterly Report on Form 10-Q, filed on March 7, 2008)
 
*
10.43
 
Purchase and Supply Agreement, dated January 14, 2008, between the Company and Scientific Protein Laboratories LLC (incorporated by reference to Exhibit 10.43 to the Company’s Quarterly Report on Form 10-Q, filed on March 7, 2008)
 
 
*
10.44
 
Amendment No. 1 to 1993 Stock Option Plan (incorporated by reference to Exhibit 10.44 to the Company’s Quarterly Report on Form 10-Q, filed on June 9, 2008)
 
*
10.45
 
Retirement Agreement, dated April 25, 2008, between the Company and Kuslima Shogen (incorporated by reference to Exhibit 99.1 to the Company’s Current Report on Form 8-K, filed on April 28, 2008)
 
 
*~
10.46
 
Securities Purchase Agreement dated October 19, 2009 by and among the Company and the investors named therein (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed on October 20, 2009)
 
 
*
10.47
 
Amendment to Securities Purchase Agreement dated February 26, 2010 by and among the Company and the investors named therein (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed on March 4, 2010)
 
 
*
10.48
 
Investors Rights Agreement dated October 19, 2009 by and among the Company and the investors named therein (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed on October 20, 2009)
 
 
*
10.49
 
Amendment to Investor Rights Agreement dated February 26, 2010 by and among the Company and the investors named therein (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K, filed on March 4, 2010)
 
 
*
10.50
 
Security Agreement dated October 19, 2009 by and among the Company, the agent named therein and the secured parties named therein (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K, filed on October 20, 2009)
 
 
*
 
 
53

 
 
Exhibit No.
  Item Title   Filed Herewith or Incorporated by Reference
     
10.51
 
Escrow Agreement by and among the Company and the parties named therein dated October 19, 2009 (incorporated by reference to Exhibit 10.4 to the Company’s Current Report 8-K, filed on October 20, 2009)
 
 
*
10.52
 
Employment Agreement by and between the Company and Charles Muniz dated October 19, 2009 (incorporated by reference to Exhibit 10.5 to the Company’s Current Report on Form 8-K, filed on October 20, 2009)
 
*~
10.53
 
Termination Agreement between the Company and Par Pharmaceutical, Inc. (incorporated by reference to Exhibit 10.51 to the Company’s Quarterly Report on Form 10-Q, filed on November 13,  2009)
 
 
*
10.54
 
Amendment to the Retirement Agreement, dated April 25, 2008, between the Company and Kuslima Shogen (incorporated by reference to Exhibit 10.52 to the Company’s Quarterly Report on Form 10-Q, filed on November 13, 2009)
 
 
*
10.55   Amendment to each 5% Senior Secured Convertible Promissory Note by and between the Company and the holders thereof dated February 26, 2010 (incorporated by reference to Exhibit 10.2 to the Company's Current Report on Form 8-K, filed on March 4, 2010)   *
10.56   Amendment to Investors Rights Agreement dated July 31, 2010 by and among the Company and the investors named therein   +
10.57
 
Office Lease Agreement, dated September 28, 2010, between Princeton Corporate Plaza, LLC and the Company
 
+
21.1
 
Subsidiaries of Registrant
 
*
23.1
 
Consent of J.H. Cohn LLP
 
+
23.2
 
Consent of KPMG LLP
 
+
31.1
 
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
 
+
31.2
 
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
 
+
32.1
 
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
 
+
 
 
*
+
Previously filed; incorporated herein by reference
Filed herewith
^
Portions of this exhibit have been redacted and filed separately with the SEC pursuant to a confidential treatment request.
~
Management contract or compensatory plan or arrangement.

 
54

 

SIGNATURE

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 

 
TAMIR BIOTECHNOLOGY, INC.
 
       
       
Dated: October 29, 2010
By:
/s/ CHARLES MUNIZ  
   
Charles Muniz, Chief Executive Officer
 
 
 
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
 
 
Dated: October 29, 2010
/s/ CHARLES MUNIZ  
  Charles Muniz, Chief Executive Officer, President,  
  Chief Financial Officer (Principal Executive Officer,  
 
Principal Financial Officer and Principal Accounting Officer)
and Director
 
     
Dated: October 29, 2010
/s/ DAVID SIDRANSKY  
 
David Sidransky, M.D., Chairman of the Board
 
     
     
Dated: October 29, 2010
/s/ JOHN P. BRANCACCIO  
  John P. Brancaccio, Director  
     
     
Dated: October 29, 2010
/s/ PAUL M. WEISS
 
 
Paul M. Weiss, Ph.D., Director
 
 

 
55

 

Tamir Biotechnology, Inc.
 
Index to Financial Statements
 
 
Page
   
Audited Financial Statements:
 
   
Report of Independent Registered Public Accounting Firm:  J.H. Cohn LLP
F - 2
   
Report of Independent Registered Public Accounting Firm:  KPMG LLP
F - 3
   
Independent Auditors’ Report of Armus, Harrison & Co.
F - 5
   
Balance Sheets - July 31, 2010 and 2009
F - 6
   
Statements of Operations - Years ended July 31, 2010 and 2009,
 
and the Period from August 24, 1981
 
(Date of Inception) to July 31, 2010
F - 7
   
Statement of Stockholders’ Equity (Deficiency)
 
Period from August 24, 1981
 
(Date of Inception) to July 31, 2010
F - 8
   
Statements of Cash Flows - Years ended July 31, 2010 and 2009,
 
and the Period from August 24, 1981
 
(Date of Inception) to July 31, 2010
F - 15
   
Notes to Financial Statements - Years ended July 31, 2010 and
 
2009 and the Period from August 24, 1981
 
(Date of Inception) to July 31, 2010
F - 18
 
 
F - 1

 

Report of Independent Registered Public Accounting Firm

The Board of Directors and Stockholders
Tamir Biotechnology, Inc.

We have audited the accompanying balance sheets of Tamir Biotechnology, Inc. (a development stage company) as of July 31, 2010 and 2009, and the related statements of operations, stockholders’ equity (deficiency) and cash flows for the years then ended and for the period from August 24, 1981 (date of inception) to July 31, 2010.  These financial statements are the responsibility of the Company’s management.  Our responsibility is to express an opinion on these financial statements based on our audits.  The financial statements of Tamir Biotechnology, Inc. for the period from August 24, 1981 to July 31, 2002 were audited by other auditors whose reports dated November 4, 2002 and December 9, 1992, except for Note 18 which is as of July 19, 1993 and Note 3 which is as of October 28, 1993, expressed unqualified opinions on those statements with explanatory paragraphs relating to the Company’s ability to continue as a going concern.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement.  An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements.  An audit also includes assessing the accounting principles used and significant estimates made by management, and as well as evaluating the overall financial statement presentation.  We believe that our audits provide a reasonable basis for our opinion.

In our opinion, based on our audits and, for the effect on the period from August 24, 1981 (date of inception) to July 31, 2010 of the amounts for the period from August 24, 1981 (date of inception) to July 31, 2002, on the reports of other auditors, the financial statements referred to above present fairly, in all material respects, the financial position of Tamir Biotechnology, Inc. as of July 31, 2010 and 2009, and its results of operations and cash flows for the years then ended and for the period from August 24, 1981 (date of inception) to July 31, 2010, in conformity with accounting principles generally accepted in the United States of America.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern.  As discussed in Note 2 to the financial statements, the Company has suffered recurring losses from operations, has a working capital deficit and negative cash flows from operating activities that raise substantial doubt about its ability to continue as a going concern.  Management’s plans in regards to these matters are also described in Note 2.  The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

/s/ J.H. Cohn LLP
Roseland, New Jersey
October 29, 2010

 
 
F - 2

 

Report Of Independent Registered Public Accounting Firm

The Stockholders and Board of Directors
Tamir Biotechnology, Inc.:

We have audited the statements of operations, stockholders' equity (deficiency), and cash flows for the period from August 24, 1981 (date of inception) to July 31, 2002 (not presented herein) of Tamir Biotechnology, Inc. (a development stage company).  These financial statements are the responsibility of the Company's management.  Our responsibility is to express an opinion on these financial statements based on our audit.  The financial statements of Tamir Biotechnology, Inc. for the period from August 24, 1981 to July 31, 1992 were audited by other auditors who have ceased operations and whose report dated December 9, 1992, except as to note 18 which is July 19, 1993 and note 3 which is October 28, 1993, expressed an unqualified opinion on those statements with an explanatory paragraph regarding the Company's ability to continue as a going concern.

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States).  Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement.  An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements.  An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation.  We believe that our audit provides a reasonable basis for our opinion.

In our opinion, based on our audit and, for the effect on the period from August 24, 1981 to July 31, 2002 of the amounts for the period from August 24, 1981 to July 31, 1992, on the report of other auditors who have ceased operations, the financial statements referred to above present fairly, in all material respects, the results of operations and cash flows for the period from August 24, 1981 to July 31, 2002 (not presented herein) of Tamir Biotechnology, Inc. in conformity with U.S. generally accepted accounting principles.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern.  As discussed in Note 2 to the financial statements, the Company has suffered recurring losses from operations, has a working capital deficit and has limited liquid resources which raise substantial doubt about its ability to continue as a going concern.  Management’s plans in regard to these matters are also described in Note 2.  The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 
                               /s/ KPMG LLP



Short Hills, New Jersey
November 4, 2002

 
 
F - 3

 

On December 1, 1993, certain shareholders of Armus Harrison & Co. (“AHC”) terminated their association with AHC (the “AHC termination”), and AHC ceased performing accounting and auditing services, except for limited accounting services to be performed on behalf of the Company.  In June 1996, AHC dissolved and ceased all operations.  The report of AHC with respect to the financial statements of the Company from inception to July 31, 1992 is included herein, although AHC has not consented to the use of such report herein and will not be available to perform any subsequent review procedures with respect to such report.  Accordingly, investors will be barred from asserting claims against AHC under Section 11 of the Securities Act of 1933, as amended (the “Se curities Act”) on the basis of the use of such report in any registration statement of the Company into which such report is incorporated by reference.  In addition, in the event any persons seek to assert a claim against AHC for false or misleading financial statements and disclosures in documents previously filed by the Company, such claim will be adversely affected and possibly barred.  Furthermore, as a result of the lack of a consent from AHC to the use of its audit report herein, or, to its incorporation by reference into a registration statement or other filings, the officers and directors of the Company will be unable to rely on the authority of AHC as experts in auditing and accounting in the event any claim is brought against such persons under Section 11 of the Securities Act based on alleged false and misleading financial statements and disclosures attributable to AHC.  The discussion regarding certain effects of the AHC termination is not meant and should not be construed in any way as legal advice to any party and any potential purchaser should consult with his, her or its own counsel with respect to the effect of the AHC termination on a potential investment in the Common Stock of the Company or otherwise.

 
 
F - 4

 
 
Independent Auditors’ Report

Board of Directors
Tamir Biotechnology, Inc.
Bloomfield, New Jersey

We have audited the balance sheets of Tamir Biotechnology, Inc. (a Development Stage Company) as of July 31, 1992 and 1991, as restated, and the related statements of operations, stockholders’ deficiency, and cash flows for the three years ended July 31, 1992, as restated, and for the period from inception August 24, 1981 to July 31, 1992, as restated.  In connection with our audit of the 1992 and 1991 financial statements, we have also audited the 1992, 1991 and 1990 financial statement schedules as listed in the accompanying index.  These financial statements and financial statement schedules are the responsibility of the Company’s management.  Our responsibility is to express an opinion on these financial statements based on our audit.

We conducted our audit in accordance with generally accepted auditing standards.  Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement.  An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements.  An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation.  We believe that our audit provides a reasonable basis for our opinion.

In our opinion the financial statements referred to above present fairly in all material respects, the financial position of Tamir Biotechnology, Inc. as of July 31, 1992 and 1991, as restated, and for the three years ended July 31, 1992, as restated, and for the period from inception August 24, 1981 to July 31, 1992, as restated, and the results of operations and cash flows for the years then ended in conformity with generally accepted accounting principles.

The accompanying financial statements have been prepared on a going concern basis which contemplates the realization of assets and the satisfaction of liability in the normal course of business.  As shown in the statement of operations, the Company has incurred substantial losses in each year since its inception.  In addition, the Company is a development stage company and its principal operation for production of income has not commenced.  The Company’s working capital has been reduced considerably by operating losses, and has a deficit net worth.  These factors, among others, as discussed in Note 2 to the Notes of Financial Statements, indicates the uncertainties about the Company’s ability to continue as a going concern.  The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and the amount or classification of liabilities that might be necessary should the Company be unable to continue its existence.
 
 
  /s/ Armus, Harrison & Co.  
 
Armus, Harrison & Co.
 
 
Mountainside, New Jersey
December 9, 1992
Except as to Note 18 which
  is July 19, 1993 and Note 3
  which is October 28, 1993
 
 
F - 5

 
 
TAMIR BIOTECHNOLOGY, INC.
(A Development Stage Company)

Balance Sheets
 
July 31, 2010 and 2009
 
 
2010
   
2009
 
ASSETS
         
           
Current assets:
         
Cash and cash equivalents
$ 321,253     $ 129,194  
Prepaid clinical trial expenses
  372,216        
Prepaid expenses
  105,233       54,494  
Restricted cash
  1,228,236        
Total current assets
  2,026,938       183,688  
Property and equipment, net of accumulated depreciation and amortization of $378,435 in 2010 and $377,134 in 2009
  32,594       108,018  
Other assets
        266,280  
Deferred financing costs
  182,063        
               
Total assets
$ 2,241,595     $ 557,986  
               
LIABILITIES AND STOCKHOLDERS’ DEFICIENCY
             
               
Current liabilities:
             
Accounts payable
$ 507,892     $ 407,273  
Accrued clinical trial expenses
  295,150       459,911  
Accrued professional service fees
  374,361       350,486  
Accrued compensation expense
  136,634       207,245  
Derivative liability
  15,479,366        
Current portion of obligations under capital lease
  5,353       4,299  
Other accrued expenses
  200,152       2,890  
Total current liabilities
  16,998,908       1,432,104  
Other liabilities:
             
Accounts payable, net of current portion
  444,223       444,223  
Obligations under capital lease, net of current portion
  7,288       12,641  
Accrued retirement benefits
  231,250       335,250  
Deferred rent
  12,386       284,134  
Convertible debt, less discount of $2,413,014 (related party, $251,093)
  836,986        
Accrued interest, convertible debt (related party, $37,664)
  125,548        
Deferred revenue
  5,200,000       5,200,000  
Total other liabilities
  6,857,681       6,276,248  
Total liabilities
  23,856,589       7,708,352  
               
Commitments and Contingencies
             
               
Stockholders’ deficiency:
             
Preferred stock, $.001 par value.  Authorized and unissued, 1,000,000 shares at July 31, 2010 and 2009
         
Common stock $.001 par value.  Authorized 250,000,000 shares and 100,000,000 shares at July 31, 2010 and 2009, respectively; issued and outstanding 47,313,880 shares at July 31, 2010 and 2009
    47,314         47,314  
Capital in excess of par value
  101,456,909       101,734,572  
Deficit accumulated during development stage
  (123,119,217 )     (108,932,252 )
Total stockholders’ deficiency
  (21,614,994 )     (7,150,366 )
               
Total liabilities and stockholders’ deficiency
$ 2,241,595     $ 557,986  
 
See accompanying notes to financial statements.
 
 
F - 6

 
TAMIR BIOTECHNOLOGY, INC.
(A Development Stage Company)
 
 Statements of Operations
 
Years ended July 31, 2010 and 2009
and the Period from August 24, 1981
(Date of Inception) to July 31, 2010
 
 
 
 
2010
   
 
 
2009
   
August 24, 1981
(date of
inception)
to July 31, 2010
 
                 
Sales
$ 18,750     $     $ 572,239  
                       
Operating expenses:
                     
Cost of sales
              336,495  
Research and development
  517,870       3,268,348       73,099,750  
General and administrative
  1,703,497       2,431,121       42,667,386  
                       
Total operating expenses
  2, 221,367       5,699,469       116, 103,631  
                       
Loss from operations
  (2,202,617 )     (5,699,469 )     (115,531,392 )
                       
Investment income
  1,132       25,633       2,303,213  
Other income
              99,939  
Interest expense:
                     
   Related parties, net
  (51,075 )           (1,198,622 )
   Debt discount and fair value adjustment – derivative security
  (12,455,267 )      –       (12,455,267 )
   Others
   (125,787 )      (5,427 )     (3,008,993 )
                       
Loss before state tax benefit
  (14, 833,614 )     (5,679,263 )     (129,791,122 )
                       
State tax benefit
  646,649       1,139,867       6,671,905  
                       
Net loss
$ (14, 186,965 )   $ (4,539,396 )   $ (123,119,217 )
                       
Loss per basic and diluted common share
$ (0.30 )   $ (0.10 )        
                       
Weighted average number of shares outstanding – basic and diluted
  47,313,000       47,313,000          

See accompanying notes to financial statements.
 
 
F - 7

 
TAMIR BIOTECHNOLOGY, INC.
(A Development Stage Company)

Statement of Stockholders' Equity (Deficiency)
 
Period from August 24, 1981
(Date of Inception) to July 31, 2010
 
 
Common Stock
                         
 
Number of Shares
 
Amount
 
Capital In
Excess of par
Value
 
Common
Stock to be
Issued
 
Deficit
Accumulated
During
Development
Stage
 
Subscription
Receivable
 
Deferred compensation, restricted stock
 
Total Stockholders’
Equity
(Deficiency)
 
                                               
Issuance of shares to officers and stockholders for equipment, research and development, and expense reimbursement
712,500   $ 713   $ 212,987   $   $   $   $   $ 213,700  
Issuance of shares for organizational legal service
50,000     50     4,950                     5,000  
Sale of shares for cash, net
82,143     82     108,418                     108,500  
Adjustment for 3 for 2 stock split declared September 8, 1982
422,321     422     (422 )                    
Net loss
—       —     —          (121,486 )           (121,486 )
Balance at July 31, 1982
1,266,964     1,267     325,933         (121,486 )           205,714  
                                             
Issuance of shares for equipment
15,000     15     13,985                     14,000  
Sale of shares to private investors
44,196     44     41,206                     41,250  
Sale of shares in public offering, net
660,000     660     1,307,786                     1,308,446  
Issuance of shares under stock grant program
20,000     20     109,980                     110,000  
Exercise of warrants, net
1,165     1     3,494                     3,495  
Net loss
                (558,694 )           (558,694 )
Balance at July 31, 1983
2,007,325     2,007     1,802,384         (680,180 )           1,124,211  
                                               
Exercise of warrants, net
287,566     287     933,696                     933,983  
Issuance of shares under stock grant program
19,750     20     101,199                     101,219  
Issuance of shares under stock bonus plan for directors and consultants
130,250     131     385,786                     385,917  
Net loss
         —         (1,421,083 )           (1,421,083 )
Balance at July 31, 1984
2,444,891     2,445     3,223,065         (2,101,263 )           1,124,247  
                                               
Issuance of shares under stock grant program
48,332     48     478,057                     478,105  
Issuance of shares under stock bonus plan for directors and consultants
99,163     99     879,379                     879,478  
Shares canceled
(42,500 )   (42 )   (105,783 )                   (105,825 )
Exercise of warrants, net
334,957     335     1,971,012                       1,971,347  
Net loss
        —          (2,958,846 )           (2,958,846 )
Balance at July 31, 1985
2,884,843     2,885     6,445,730         (5,060,109 )           1,388,506  
                                               
Issuance of shares under stock grant program
11,250     12     107,020                     107,032  
Issuance of shares under stock bonus plan for directors and consultants
15,394     15     215,385                     215,400  
Exercise of warrants, net
21,565     21     80,977                     80,998  
Net loss
                (2,138,605 )           (2,138,605 )
Balance at July 31, 1986 (carried forward)
2,933,052     2,933     6,849,112         (7,198,714 )           (346,669 )
 
 
F - 8

 
TAMIR BIOTECHNOLOGY, INC.
(A Development Stage Company)
 
Statement of Stockholders' Equity (Deficiency), Continued

 
Common Stock
                         
 
Number of Shares
 
 
Amount
 
 
Capital In
Excess of par
Value
 
 
Common
Stock to be
Issued
 
Deficit
Accumulated
During
Development
Stage
 
 
 
Subscription
Receivable
 
 
Deferred compensation, restricted stock
 
Total Stockholders’
Equity
(Deficiency)
 
                                 
 Balance at July 31, 1986 (brought forward)
2,933,052   $ 2,933   $ 6,849,112   $   $ (7,198,714 ) $   $   $ (346,669 )
                                               
 Exercise of warrants, net
14,745     15     147,435                     147,450  
 Issuance of shares under stock bonus plan for directors and consultants
5,000     5     74,995                     75,000  
 Issuance of shares for services
250,000     250     499,750                     500,000  
 Sale of shares to private investors, net
5,000     5     24,995                     25,000  
 Net loss
—       —     —          (2,604,619 )           (2,604,619 )
 Balance at July 31, 1987
3,207,797     3,208     7,596,287         (9,803,333 )           (2,203,838 )
                                               
 Issuance of shares for legal and consulting services
206,429     207     724,280                     724,487  
 Issuance of shares under employment incentive program
700,000     700     2,449,300                 (2,450,000 )    
 Issuance of shares under stock grant program
19,000     19     66,481                     66,500  
 Exercise of options, net
170,000     170     509,830                     510,000  
 Issuance of shares for litigation settlement
12,500     12     31,125                     31,137  
 Exercise of warrants, net
63,925     64     451,341                     451,405  
 Sale of shares to private investors
61,073     61     178,072                     178,133  
 Amortization of deferred compensation, restricted stock
                        449,167     449,167  
 Net loss
—             —          (3,272,773 )       —      (3,272,773 )
 Balance at July 31, 1988
4,440,724     4,441     12,006,716         (13,076,106 )       (2,000,833 )   (3,065,782 )
                                             
 Sale of shares for litigation settlement
135,000     135     1,074,703                     1,074,838  
 Conversion  of debentures, net
133,333     133     399,867                     400,000  
 Sale of shares to private investors
105,840     106     419,894                     420,000  
 Exercise of options, net
1,000     1     3,499                     3,500  
 Issuance of shares under employment agreement
750,000     750     3,749,250                 (3,750,000 )    
 Issuance of shares under the 1989 Stock Plan
30,000     30     149,970                 (150,000 )    
 Amortization of deferred compensation, restricted stock
                        1,050,756     1,050,756  
 Net loss
    —      —           (2,952,869 )       —      (2,952,869 )
 Balance at July 31, 1989
5,595,897     5,596     17,803,899         (16,028,975 )       (4,850,077 )   (3,069,557 )
                                               
 Issuance of shares for legal and consulting services
52,463     52     258,725                     258,777  
 Issuance of shares under the 1989 Stock Plan
56,000     56     335,944                 (336,000 )    
 Sale of shares for litigation settlement
50,000     50     351,067                     351,117  
 Exercise of options at, net 105,989     106      345,856                     345,962  
 
 
F - 9

 
TAMIR BIOTECHNOLOGY, INC.
(A Development Stage Company)

Statement of Stockholders' Equity (Deficiency), Continued

 
Common Stock
                         
 
Number of Shares
 
 
Amount
 
 
Capital In
Excess of par
Value
 
 
Common
Stock to be
Issued
 
Deficit
Accumulated
During
Development
Stage
 
 
 
Subscription
Receivable
 
 
Deferred compensation, restricted stock
 
Total Stockholders’
Equity
(Deficiency)
 
                                 
 Sale of shares to private investors
89,480   $ 90   $ 354,990   $   $   $   $   $ 355,080  
 Issuance of shares under employment agreement
750,000     750     3,749,250                 (3,750,000 )    
 Conversion of debentures, net
100,000     100     499,900                     500,000  
 Amortization of deferred compensation, restricted stock
                        3,015,561     3,015,561  
 Net loss
        —          (4,860,116 )       —      (4,860,116 )
 Balance at July 31, 1990
6,799,829     6,800     23,699,631         (20,889,091 )       (5,920,516 )   (3,103,176 )
                                               
Exercise of options, net
16,720     16     108,664                     108,680  
Issuance of shares for legal consulting services
87,000     87     358,627                     358,714  
Issuance of shares under the 1989 Stock Plan
119,000     119     475,881                 (476,000 )    
Amortization of deferred compensation, restricted stock
                        2,891,561     2,891,561  
Net loss
     —     —          (5,202,302 )       —      (5,202,302 )
Balance at July 31, 1991
7,022,549     7,022     24,642,803         (26,091,393 )       (3,504,955 )   (4,946,523 )
                                               
Exercise of options at, net
1,000     1     3,499                     3,500  
Sale of shares to private investors
70,731     71     219,829                     219,900  
Conversion of debentures, net
94,000     94     469,906                     470,000  
Issuance of shares for services
45,734     46     156,944                     156,990  
Issuance of shares under the 1989 Stock Plan
104,000     104     285,896                 (286,000 )    
Amortization of deferred compensation, restricted stock
                        3,046,726     3,046,726  
Net loss
     —     —          (4,772,826 )       —      (4,772,826 )
Balance at July 31, 1992
7,338,014     7,338     25,778,877         (30,864,219 )       (744,229 )   (5,822,233 )
                                               
Sale of shares to private investors
352,667     353     735,147                     735,500  
Issuance of shares for legal services
49,600     50     132,180                     132,230  
Issuance of shares for services
5,000     5     9,995                 (10,000 )    
Issuance of shares under the 1989 Stock Plan
117,000     117     233,883                 (234,000 )    
Amortization of deferred compensation, restricted stock
                        664,729     664,729  
Net loss
     —     —          (2,357,350 )       —      (2,357,350 )
Balance at July 31, 1993
7,862,281     7,863     26,890,082         (33,221,569 )       (323,500 )   (6,647,124 )
                                               
Conversion of debentures, net
425,400     425     1,701,575                     1,702,000  
Sale of shares to private investors, net
743,000     743     1,710,048                     1,710,791  
Conversion of short-term borrowings
72,800     73     181,927                     182,000  
Issuance of shares for services
16,200     16     43,334                     43,350  
 
 
F - 10

 
 
TAMIR BIOTECHNOLOGY, INC.
(A Development Stage Company)
 
Statement of Stockholders’ Equity (Deficiency), Continued
 
 
Common Stock
                         
 
Number of Shares
 
 
Amount
 
 
Capital In
Excess of par
Value
 
 
Common
Stock to be
Issued
 
Deficit
Accumulated
During
Development
Stage
 
 
 
Subscription
Receivable
 
 
Deferred compensation, restricted stock
 
Total Stockholders’
Equity
(Deficiency)
 
                                 
 Issuance of shares under the 1989 Stock Plan, for services 5,000   $ 5   $ 14,995   $   $   $   $   $ 15,000  
Issuance of options to related parties upon conversion of accrued interest, payroll and expenses
        3,194,969                     3,194,969  
Repurchase of stock options from related party
        (198,417 )                   (198,417 )
Issuance of options upon conversion of accrued interest
        142,441                     142,441  
Common stock to be issued
            50,000                 50,000  
Amortization of deferred compensation, restricted stock
                        265,000     265,000  
Net loss
     —     —       —     (2,234,428 )       —      (2,234,428 )
Balance at July 31, 1994
9,124,681     9,125     33,680,954     50,000     (35,455,997 )       (58,500 )   (1,774,418 )
                                               
Sale of shares to private investors, net
961,000     961     2,023,241     (50,000 )               1,974,202  
Conversion of short-term borrowings
17,600     17     43,983                     44,000  
Issuance of shares for services
30,906     31     77,234                     77,265  
Exercise of options, net
185,000     185     437,015                     437,200  
Common stock to be issued
            339,008                 339,008  
Common stock to be issued, for services
            4,800                 4,800  
Amortization of deferred compensation, restricted stock
                        58,500     58,500  
Net loss
—          —          (1,993,123 )           (1,993,123 )
Balance at July 31, 1995
10,319,187     10,319     36,262,427     343,808     (37,449,120 )           (832,566 )
                                               
Sale of shares to private investors, net
2,953,327     2,953     8,969,655     (339,008 )               8,633,600  
Issuance of shares for services
19,995     20     70,858     (4,800 )               66,078  
Exercise of options, net
566,700     567     1,657,633                     1,658,200  
Sale of warrants
        12,084                     12,084  
Issuance of options/warrants for services
        50,872                     50,872  
Common stock to be issued
            258,335                 258,335  
Subscription receivable
                    (254,185 )       (254,185 )
Net loss
—          —          (2,942,152 )           (2,942,152 )
Balance at July 31, 1996
13,859,209     13,859     47,023,529     258,335     (40,391,272 )   (254,185 )       6,650,266  
                                               
Sale of shares to private investors, net
112,000     112     503,888                     504,000  
Issuance of options for services
        76,504                     76,504  
Exercise of options, net
729,134     729     2,620,359     (258,335 )       254,185         2,616,938  
Exercise of warrants, net
147,450     148     737,102                     737,250  
Net loss
        —          (5,018,867 )           (5,018,867 )
Balance at July 31, 1997 (carried forward)
14,847,793     14,848     50,961,382         (45,410,139 )           5,566,091  
 
 
F - 11

 
 
TAMIR BIOTECHNOLOGY, INC.
(A Development Stage Company)
 
Statement of Stockholders' Equity (Deficiency), Continued
 
 
Common Stock
                         
 
Number of Shares
 
 
Amount
 
 
Capital In
Excess of par
Value
 
 
Common
Stock to be
Issued
 
Deficit
Accumulated
During
Development
Stage
 
 
 
Subscription
Receivable
 
 
Deferred compensation, restricted stock
 
Total Stockholders’
Equity
(Deficiency)
 
                                 
Balance at July 31, 1997 (brought forward)
14,847,793   $ 14,848   $ 50,961,382   $   $ (45,410,139 ) $   $   $ 5,566,091  
                                               
Sale of shares to private investors, net
2,337,150     2,337     4,199,877                     4,202,214  
Issuance of options for services
        199,954                     199,954  
Exercise of warrants, net
4,950     5     11,080                     11,085  
Issuance of shares for services, net
50,000     50     99,950                     100,000  
Net loss
—          —          (6,387,506 )           (6,387,506 )
Balance at July 31, 1998
17,239,893     17,240     55,472,243         (51,797,645 )           3,691,838  
                                               
Issuance of options for services
        205,593                     205,593  
Issuance of shares for services, net
46,701     46     16,359                     16,405  
Net loss
—          —          (3,156,636 )           (3,156,636 )
Balance at July 31, 1999
17,286,594     17,286     55,694,195         (54,954,281 )           757,200  
                                               
Sale of shares to private investors, net
875,000     875     547,417                     548,292  
Exercise of options, net
95,000     95     45,755                     45,850  
Issuance of shares for services, net
174,965     175     92,009                     92,184  
Vesting of options previously issued for services
        146,912                     146,912  
Net loss
—          —        —     (1,722,298 )    —      —     (1,722,298 )
Balance at July 31, 2000
18,431,559     18,431     56,526,288         (56,676,579 )           (131,860 )
Sale of shares to private investors, net
863,331     863     955,561                     956,424  
Exercise of options, net
165,555     166     83,565                     83,731  
Issuance of shares for services, net
11,800     12     10,018                     10,030  
Exercise of convertible debentures, net
330,000     330     296,670                     297,000  
Issuance of warrants with convertible debt
        178,807                     178,807  
Issuance of options for services
        160,426                     160,426  
Net loss
—          —        —     (2,294,936 )    —      —     (2,294,936 )
Balance at July 31, 2001
19,802,245     19,802     58,211,335         (58,971,515 )           (740,378 )
Sale of shares to private investors, net
2,622,122     2,623     1,047,925                     1,050,548  
Exercise of stock options and warrants
186,000     186     92,814                     93,000  
Issuance of shares for services, net
78,340     78     64,048                     64,126  
Exercise of convertible debentures, net
72,214     72     64,921                     64,993  
Vesting of options previously issued for services
        173,436                     173,436  
Net loss
—          —        —     (2,591,162 )    —      —     (2,591,162 )
Balance at July 31, 2002 (carried forward)
22,760,921     22,761     59,654,479         (61,562,677 )           (1,885,437 )
 
 
F - 12

 
 
TAMIR BIOTECHNOLOGY, INC.
(A Development Stage Company)
 
Statement of Stockholders' Equity (Deficiency), Continued
 
 
Common Stock
                         
 
Number of Shares
 
 
Amount
 
 
Capital In
Excess of par
Value
 
 
Common
Stock to be
Issued
 
Deficit
Accumulated
During
Development
Stage
 
 
 
Subscription
Receivable
 
 
Deferred compensation, restricted stock
 
Total Stockholders’
Equity
(Deficiency)
 
                                 
Balance at July 31, 2002 (brought forward)
22,760,921   $ 22,761   $ 59,654,479   $   $ (61,562,677 ) $   $   $ (1,885,437 )
                                               
Sale of shares to private investors, net
1,315,000     1,315     652,312                     653,627  
Exercise of stock options and warrants
764,000     764     376,896                     377,660  
Issuance of shares for payment of accounts payable
186,208     186     94,037                     94,223  
Issuance of options for services rendered
        75,521                     75,521  
Vesting of options previously issued for services
        10,038                     10,038  
Issuance of warrants in connection with debt issuances
        594,219                     594,219  
Net loss
—          —        —     (2,411,532 )    —      —     (2,411,532 )
Balance at July 31, 2003
25,026,129     25,026     61,457,502         (63,974,209 )           (2,491,681 )
Sale of shares to private investors, net
3,035,200     3,036     10,732,942                     10,735,978  
Exercise of stock options and warrants
3,100,160     3,100     4,155,397                     4,158,497  
Issuance of shares for payment of accounts payable
14,703     15     52,161                     52,176  
Issuance of shares for conversion of subordinated debentures
3,042,817     3,043     924,829                     927,872  
Issuance of shares for services rendered
128,876     128     288,372                     288,500  
Issuance of options for services rendered
        280,612                     280,612  
Net loss
—          —        —     (5,070,307 )    —      —     (5,070,307 )
Balance at July 31, 2004
34,347,885     34,348     77,891,815         (69,044,516 )           8,881,647  
Exercise of stock options and warrants, net
438,372     438     306,717                     307,155  
Issuance of shares and warrants for conversion of subordinated debentures
1,744,978      1,745     462,754                     464,499  
Issuance of shares for services rendered
3,000     3     13,497                     13,500  
Issuance of options and warrants for services rendered
        16,789                     16,789  
Net loss
—          —        —     (6,461,920 )    —      —     (6,461,920 )
Balance at July 31, 2005
36,534,235     36,534     78,691,572         (75,506,436 )           3,221,670  
Sale of shares to private investors, net
6,632,099     6,632     10,977,288                     10,983,920  
Exercise of stock options and warrants, net
1,122,827     1,123     1,347,201                     1,348,324  
Issuance of stock options and warrants for services rendered
        1,489,264                     1,489,264  
Net loss
—          —        —     (7,810,175 )    —      —     (7,810,175 )
Balance at July 31, 2006 (carried forward)
44,289,161     44,289     92,505,325         (83,316,611 )           9,233,003  
 
 
F - 13

 

TAMIR BIOTECHNOLOGY, INC.
(A Development Stage Company)
 
Statement of Stockholders' Equity (Deficiency), Continued
 
 
Common Stock
                         
 
Number of Shares
 
 
Amount
 
 
Capital In
Excess of par
Value
 
 
Common
Stock to be
Issued
 
Deficit
Accumulated
During
Development
Stage
 
 
 
Subscription
Receivable
 
 
Deferred compensation, restricted stock
 
Total Stockholders’
Equity
(Deficiency)
 
                                 
Balance at July 31, 2006 (brought forward)
44,289,161   $ 44,289   $ 92,505,325   $   $ (83,316,611 ) $   $   $ 9,233,003  
Sale of shares to private investors, net
553,360     553     1,368,104                     1,368,657  
Exercise of stock options and warrants, net
1,438,359     1,439     1,504,261                     1,505,700  
Share-based compensation expense
        2,426,264                     2,426,264  
Net loss
—          —        —     (8,755,144 )    —      —     (8,755,144 )
Balance at July 31, 2007
46,280,880     46,281     97,803,954         (92,071,755 )           5,778,480  
Exercise of stock options and warrants, net
996,000     996     686,044                     687,040  
Share-based compensation expense
        2,298,975                     2,298,975  
Net loss
—          —        —     (12,321,101 )    —      —     (12,321,101 )
Balance at July 31, 2008
47,276,880     47,277     100,788,973         (104,392,856 )           (3,556,606 )
Exercise of stock options and warrants, net
37,000     37     13,183                     13,220  
Share-based compensation expense
        932,416                     932,416  
Net loss
 —          —        —     (4,539,396 )    —      —     (4,539,396 )
Balance at July 31, 2009
47,313,880     47,314     101,734,572         (108,932,252 )           (7,150,366 )
                                               
Share-based compensation expense
        333,422                     333,422  
Derivative liability
        (611,085 )                   (611,085 )
Net loss
 —          —        —     (14,186,965 )    —      —     (14,186,965 )
Balance at July 31, 2010
47,313,880   $ 47,314   $ 101,456,909   $   $ (123,119,217 ) $   $   $ (21,614,994 )
 
See accompanying notes to financial statements.
 
 
F - 14

 

TAMIR BIOTECHNOLOGY, INC.
(A Development Stage Company)
 
Statements of Cash Flows
 
Years ended July 31, 2010 and  2009
and the Period from August 24, 1981
(Date of Inception) to July 31, 2010
 
 
 
 
2010
   
 
 
2009
   
August 24, 1981
(date of inception) to
July 31, 2010
 
Cash flows from operating activities:
               
Net loss
$ (14,186,965 )   $ (4,539,396 )   $ (123,119,217 )
Adjustments to reconcile net loss to net cash used in operating activities:
                     
Gain on sale of marketable equity securities
  --       --       (25,963 )
Depreciation and amortization
  78,172       35,103       1,823,766  
Loss on disposal of property and equipment
  --       --       18,926  
Loss on lease termination
  --       --       30,964  
Share-based compensation expense
  333,422       932,416       14,197,354  
(Decrease) increase in deferred rent
  (271,748 )     16,466       (85,578 )
Amortization of debt discount
  836,986       --       1,431,205  
Fair value of derivative liability
  11,618,281       --       11,618,281  
Amortization of deferred financing costs
  44,705       --       44,705  
Amortization of deferred compensation
  --       --       11,442,000  
Changes in assets and liabilities:
                     
Decrease (increase) in prepaid expenses
  (422,955 )     110,765       (537,316 )
Decrease in loans receivable, related party
  --       --       96,051  
Decrease (increase) in restricted cash
  (961,956 )     83,720       (1,228,236 )
Increase in loans and interest payable, related party
  51,075       --       795,614  
Increase (decrease) in accounts payable
  100,619       (400,982 )     1,458,750  
Increase in accrued payroll and expenses, related parties
  --       --       2,348,145  
(Decrease) increase in accrued retirement benefits
  (188,692 )     (94,308 )     329,000  
Increase (decrease) in accrued expenses
  144,930       (686,013 )     1,701,903  
Increase in deferred revenue
   --        --       5,200,000  
Net cash used in operating activities
  (2,824,126 )     (4,542,229 )     (72,459,646 )
Cash flows from investing activities:
                     
Purchase of marketable equity securities
  --       --       (290,420 )
Purchase of short-term investments
  --       --       (1,993,644 )
Proceeds from sale of marketable equity securities
  --       --       316,383  
          Proceeds from sale of short-term investments
  --       --       1,993,644  
Capital expenditures
  (2,748 )     --       (1,607,814 )
Patent costs
   --        --       (97,841 )
Net cash used in investing activities
  (2,748 )      --       (1,679,692 )
 
 
F - 15

 
 
TAMIR BIOTECHNOLOGY, INC.
(A Development Stage Company)
 
Statements of Cash Flows, Continued
 
 
 
 
2010
   
 
 
2009
   
August 24, 1981
(date of inception) to
July 31, 2010
 
Cash flows from financing activities:
               
Proceeds from short-term borrowings
$  --     $  --     $ 874,500  
Payment of short-term borrowings
  --       --       (653,500 )
Increase in loans payable, related party, net
  --       --       2,628,868  
Proceeds from bank debt and other long-term debt, net of deferred debt costs
  --       --       3,667,460  
Reduction of bank debt and long-term debt
  --       --       (2,966,568 )
Increase in deferred financing costs
  (226,768 )     --       (226,768 )
Payment of capital lease obligation
  (4,299 )     (3,453 )     (11,137 )
Proceeds from issuance of common stock, net
  --       --       53,102,893  
Proceeds from exercise of stock options and warrants, net
  --       13,220       14,080,850  
Proceeds from issuance of convertible debentures, related party
  1,000,000       --       1,297,000  
Proceeds from issuance of convertible debentures, unrelated party
  2,250,000        --       2,666,993  
Net cash provided by financing activities
  3,018,933        9,767       74,460,591  
Net increase (decrease) in cash and cash equivalents
  192,059       (4,532,462 )     321,253  
Cash and cash equivalents at beginning of period
  129,194       4,661,656        --  
Cash and cash equivalents at end of period
$ 321,253     $ 129,194     $ 321,253  
                       
Supplemental disclosure of cash flow information – interest paid
$ 6,609     $ 5,427     $ 1,729,869  
                       
Noncash investing and financing activities:
                     
Issuance of convertible subordinated debenture for loan payable to officer
$ -     $ -     $ 2,725,000  
                       
Issuance of common stock upon the conversion of convertible subordinated debentures, related party
$ -     $  -     $ 3,242,000  
                       
Conversion of short-term borrowings to common stock
$ -     $ -     $ 226,000  
                       
Conversion of accrued interest, payroll and expenses by related parties to stock options
$ -     $  -     $ 3,194,969  
                       
Repurchase of stock options from related party
$ -     $  -     $ (198,417 )
                       
Conversion of accrued interest to stock options
$ -     $ -     $ 142,441  
                       
Conversions of accounts payable to common stock
$ -     $  -     $ 506,725  
 
 
F - 16

 
 
TAMIR BIOTECHNOLOGY, INC.
(A Development Stage Company)
 
Statements of Cash Flows, Continued
 
 
 
 
2010
   
 
 
2009
   
August 24, 1981
(date of inception) to
July 31, 2010
 
                 
Conversion of notes payable, bank and accrued interest to long-term debt
$ -     $ -     $ 1,699,072  
                       
Conversion of loans and interest payable, related party and accrued payroll and expenses, related parties to long-term accrued payroll and other, related party
$  -     $  -     $ 1,863,514  
                       
Issuance of common stock and warrants upon the conversion of convertible subordinated debentures and accrued interest, other
$ -     $ -     $ 1,584,364  
                       
Issuance of common stock for services rendered
$ -     $ -     $ 2,460  
                       
Lease incentive allowance
$ -     $ -     $ 67,000  
                       
Derivative liability – warrant reclassification
$ 611,085     $ -     $ 611,085  
                       
Issuance of warrants with notes payable
$ -     $ -     $ 594,219  
                       
Acquisition of equipment through capital lease obligation
$ -     $ -     $ 23,778  
 
See accompanying notes to financial statements.

 
F - 17

 

TAMIR BIOTECHNOLOGY, INC.
(A Development Stage Company)

Notes to Financial Statements
 
Years ended July 31, 2010 and  2009
and the Period From August 24, 1981
(Date of Inception) to July 31, 2010
 
(1)      Summary of Significant Accounting Policies

Business Description

Tamir Biotechnology, Inc. (formerly known as Alfacell Corporation) (the "Company") was incorporated in Delaware on August 24, 1981 for the purpose of engaging in the discovery, investigation and development of a new class of anti-cancer drugs and anti-viral agents.  The Company is a development stage company as defined in the Accounting Standards Codification (“ASC”) “Development Stage Entities.”  The Company is devoting substantially all of its present efforts to establishing its business.  Its planned principal operations have not commenced and, accordingly, no significant revenue has been derived therefrom.

The Company is engaged in the research, development, and commercialization of drugs for the treatment of various forms of cancer and other life threatening diseases.  As of July 31, 2010, the Company is pursuing various available strategic alternatives to raise additional funds.  The Company plans to continue the further development of its drug product candidates, which requires substantial capital for research, product development, and market development activities.  The Company has not yet initiated marketing of a commercial drug product. Future product development will require clinical testing, regulatory approval, and substantial additional investment prior to commercialization.  The future success of the Company is dependent on its ability to make progress in the dev elopment of its drug product candidates and, ultimately, upon its ability to attain future profitable operations through the successful manufacturing and marketing of those drug product candidates.  There can be no assurance that the Company will be able to obtain the necessary financing or regulatory approvals to be able to successfully develop, manufacture, and market its products, or attain successful future operations.  Accordingly, the Company’s future success is uncertain.

In addition, uncertainty exists as to the Company’s ability to protect its rights to patents and its proprietary information.  There can also be no assurance that research and discoveries by others will not render some or all of the Company’s technology or drug product candidates noncompetitive or obsolete.  Nor can there be any assurance that unforeseen problems will not develop with the Company’s technologies or applications, or that the Company will be able to address successfully technological challenges it encounters in its research and development programs.  While the Company maintains insurance to cover the use of its drug product candidates in clinical trials, it does not maintain insurance covering the sale of its products nor is there any assurance that it will be able to obtain or maintain such insurance on acceptable terms or with adequate coverage against potential liabilities.

Use of Estimates

The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting period.  Actual results could differ from those estimates.

Cash Equivalents

The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. The carrying value of these investments approximates their fair market value due to their short maturity and liquidity.  The Company maintains cash deposits with banks that at times exceed applicable insurance limits.

 
F - 18

 
 
Property and Equipment

Property and equipment is recorded at cost and is depreciated using the straight-line method over the estimated useful lives of the respective assets.  Maintenance and repairs that do not extend the life of assets are charged to expense when incurred.  When assets are retired or otherwise disposed of, the cost and related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in operations for the period in which the transaction takes place.  Total depreciation and amortization expense for the years ended July 31, 2010 and 2009 was $78,172 and $35,103, respectively.

Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable.  Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted cash flows expected to be generated by the asset.  If the carrying amount exceeds its estimated future cash flows, an impairment charge is recognized in the amount by which the carrying amount exceeds the fair value of the asset.

Other Assets

Other assets consist of the following:
 
   
2010
   
2009
 
Lease security deposit held by a bank as collateral for a standby letter of credit in favor of the Company.  The cash held by the bank is restricted as to use for the term of the standby letter of credit.  In February 2010, this amount was drawn by the landlord as a court judgment in their favor.
        -     $   266,280  

Income Taxes

Income taxes are accounted for under the asset and liability method.  Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards.  Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.  The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.  Management provides valuation allowances against the deferred tax assets for amounts which a re not considered “more likely than not” to be realized.

Revenue Recognition

The Company recognizes revenue in accordance with Staff Accounting Bulletin (“SAB”) No. 104, “Revenue Recognition” issued by the staff of the SEC.  Under SAB No. 104, revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred and/or services have been rendered, the sales price is fixed or determinable, and collectibility is reasonably assured.

The Company enters into marketing and distribution agreements, which contain multiple deliverables.  Under the provisions of ASC, “Revenue Recognition - Multiple Deliverable Revenue Arrangements”, the Company evaluates whether these deliverables constitute separate units of accounting to which total arrangement consideration is allocated.  A deliverable qualifies as a separate unit of accounting when the item delivered to the customer has standalone value, there is objective and reliable evidence of fair value of items that have not been delivered to the customer, and, if there is a general right of return for the items delivered to the customer, delivery or performance of the undelivered items is considered probable and substantially in the control of the Company.  Arrangem ent consideration is allocated to units of accounting on a relative fair-value basis or the residual method if the Company is unable to determine the fair value of all deliverables in the arrangement. Consideration allocated to a unit of accounting is limited to the amount that is not contingent upon future performance by the Company.  Upon determination of separate units of accounting and allocated consideration, the general criteria for revenue recognition are applied to each unit of accounting.

 
F - 19

 
 
The Company has entered into an agreement with USP Pharma Spolka Z.O.O. (USP) to market, sell and distribute ONCONASE® in Poland and other countries in Eastern Europe.  The Company received a $0.1 million upfront nonrefundable fee in July 2007 and is entitled to receive future additional fees, milestone payments and royalties.  USP is responsible for all commercial costs in the territory.  The Company has agreed to provide or arrange for contract manufacture of a commercial supply of ONCONASE® upon receipt of marketing approval in the territory.  The up-front nonrefundable fee received by the Company will be rec ognized ratably as revenue once the general criteria for revenue recognition has been met for the unit of accounting to which the fee has been allocated.

In January 2008, the Company entered into a marketing and distribution agreement with BL&H Co. Ltd. for the commercialization of ONCONASE® in Korea, Taiwan and Hong Kong. Under the agreement, the Company received a $0.1 million up-front fee and are eligible to receive additional cash milestones and 50% of net sales in the territory. The Company will be responsible for the manufacture and supply of ONCONASE® to BL&H, while BL&H will be responsible for all activities and costs related to regulatory filings and commercial activities in the territory.

In January 2008, the Company entered into a U.S. License Agreement for ONCONASE® with Par Pharmaceutical, Inc. (“Par”).  Under the terms of the License Agreement, Strativa Pharmaceuticals (“Strativa”), the proprietary products division of Par, received exclusive marketing, sales and distribution rights to ONCONASE® for the treatment of cancer in the United States and its territories.  The Company retained all rights and obligations for product manufacturing, clinical development and obtaining regulatory approvals, as well as all rights for those non-U.S. jurisdictions in which the Company has not currently g ranted any such rights or obligations to third parties.  The Company received a cash payment of $5 million upon the signing of the License Agreement and would have been entitled to additional development and sales milestone payments and double-digit royalties on net sales of ONCONASE®.

On September 8, 2009, the Company and Par entered into a Termination and Mutual Release Agreement (the “Termination Agreement”) pursuant to which the Company’s License Agreement and Supply Agreement with Par were terminated. The License Agreement was terminated and all rights under the license granted to Par revert back to the Company under the Termination Agreement.  Under the Supply Agreement, the Company had agreed to supply all of Par’s requirements for ONCONASE®. Pursuant to the Termination Agreement, Par will be entitled to a royalty of 2% of net sales of ONCONAS E® or any other ranpirnase product developed by the Company for use in the treatment of cancer in the United States and its territories commencing with the first sale of such product and terminating upon the later to occur of the 12th anniversary of the first sale and the date of expiration of the last valid claim of a pending application or issued patent owned or controlled by the Company with respect to such product.

The Company has evaluated both the License Agreement and the Termination Agreement and has determined that the Company is obligated to provide royalty payments in the event the Company has net sales.  As such, as of July 31, 2010, the Company has not recognized into income any of the $5 million upfront payment received under the License Agreement.

Research and Development

Research and development costs are expensed as incurred.  These costs include, among other things, consulting fees and costs related to the conduct of human clinical trials.  The Company also allocates indirect costs, consisting primarily of operational costs for administering research and development activities, to research and development expenses.

Share-Based Compensation

In December 2004, the Financial Accounting Standards Board (“FASB”) issued amended guidance on accounting for Stock Compensation.  The amended guidance requires all share-based payments, including stock option grants to employees, to be recognized as an operating expense in the statement of operations.  The expense is recognized over the requisite service period based on fair values measured on the date of grant.  The Company adopted the amended guidance on Stock Compensation effective August 1, 2005 using the modified prospective method and, accordingly, prior period amounts have not been restated.  Under the modified prospective method, the fair value of all new stock options issued after July 31, 2005 and the unamortized fair value of unvested outstanding stock options at August 1, 2005 are recognized as expense as services are rendered.

 
F - 20

 
 
Shares, warrants and options have been issued to non-employees for services.  The fair value of such securities is recorded as an expense and additional paid-in capital in stockholders’ equity (deficiency) over the applicable service periods using variable accounting through the vesting date based on the fair value of the securities at the end of each period or the vesting date.

The Company recorded the following share-based compensation expense for employees based on the fair value of stock options:

   
Year Ended July 31,
 
   
2010
   
2009
 
                 
Research and development
  $ 16,808     $ 347,257  
General and administrative
    316,614       585,159  
Total share-based compensation expense
  $ 333,422     $ 932,416  
Basic and diluted loss per common share
  $ 0.01     $ .02  

At July 31, 2008, the Company reversed a total of $1,225,112 compensation expense related to 1,072,489 performance stock options issued to employees in May 2007.  The Company assessed that the performance condition tied to these stock options is deemed improbable; therefore, no compensation expense should be recognized in accordance to the guidance on accounting for Stock Compensation.

The fair value of the stock options at the grant date was estimated using the Black-Scholes option pricing model based on the weighted-average assumptions as noted in the following table.  The risk-free interest rate for periods approximating the expected life of the option is based on the U.S. Treasury yield curve in effect at the time of grant.  The expected stock price volatility is based on historical volatility of the Company’s stock price.  For post July 31, 2005 grants, the expected term until exercise is derived using the “simplified” method as allowed under the provisions of the SEC’s SAB No. 110, “Disclosures about Fair Value of Financial Instruments” and represents the period of time that options granted are expected to be outstanding.

 
2010
 
2009
       
Expected dividend yield
0%
 
0%
Risk-free interest rate
2.17%
 
1.00%
Expected volatility
120.63%
 
102.13%
Expected term (years)
4.66
 
3.5
Weighted average fair value of options at grant date
$ 0.25
 
$ 0.16
Weighted average fair value exercise price
$ 0.30
 
$ 0.16

As of July 31, 2010, there was approximately $774,000 of total unrecognized compensation expense related to unvested options granted to employees that is expected to be recognized over a weighted average period of 2.35 years.

Accounting For Warrants Issued With Convertible Debt

The Company accounts for the intrinsic value of beneficial conversion rights arising from the issuance of convertible debt instruments with non-detachable conversion rights that are in-the-money at the commitment date pursuant to the consensuses of ASC “Debt:  Debt With Conversion and Other Options”.  Such value is allocated to additional paid–in capital and the resulting debt discount is charged to interest expense over the terms of the notes payable.  Such value is determined after first allocating an appropriate portion of the proceeds received to warrants or any other detachable instruments included in the exchange.

Leases

With respect to our operating leases, the Company applies the provisions of FASB Topic “Accounting for Leases”, recognizing rent expense on a straight-line basis over the lease term due to escalating lease payments and landlord incentives.

 
F - 21

 
 
Contingencies

Liabilities for loss contingencies arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount of the liability can be reasonably estimated. Recoveries from other parties are recorded when realized.

Fair Value of Financial Instruments

Financial instruments consist primarily of cash and cash equivalents, accounts payable and convertible debt.  The carrying value of these financial instruments approximates fair value due to the relative short term nature of these investments and the carrying value of the convertible debt approximates their fair value due to the recent issuance of the convertible debt.

Recent Accounting Pronouncements

In June 2009, the FASB issued the FASB Accounting Standards Codification (the “Codification”).  Effective July 1, 2009, the Codification became the single source of authoritative nongovernmental U.S. generally accepted accounting principles (GAAP), superseding existing rules and related literature issued by FASB, the American Institute of Certified Public Accountants (“AICPA”) and Emerging Issues Task Force (“EITF”).  The Codification also eliminates the previous U.S. GAAP hierarchy and establishes one level of authoritative GAAP.  Rules and interpretive releases of the SEC under authority of federal securities laws are also sources of authoritative GAAP for SEC registrants.  All other literature is considered non-authoritative.  T he Codification, which has not changed GAAP, was effective for interim and annual periods ended after September 15, 2009.  The Company adopted the Codification for the quarter ended October 31, 2009.  Other than the manner in which accounting guidance is referenced, the adoption of the Codification had no impact on the Company’s financial statements.

In December 2007, FASB issued new accounting guidance related to the accounting for business combinations and related disclosures.  This guidance establishes principles and requirements for how an acquirer recognizes and measures in its financial statements the identifiable assets acquired, the liabilities assumed, any noncontrolling interest in the acquiree, and any goodwill acquired in a business combination.  It also establishes disclosure requirements to enable the evaluation of the nature and financial effects of a business combination.  The guidance is to be applied prospectively to business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008.  The Company adopted this guidance, effective August 1, 2009, and it did not have any effect on the Company’s financial statements.

In February 2008, FASB issued amended guidance to delay the fair value measurement and expanded disclosures about fair value measurements for nonfinancial assets and nonfinancial liabilities, except for items that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually), until fiscal years beginning after November 15, 2008.  Effective August 1, 2009, the Company adopted the guidance related to fair value measurements for nonfinancial assets and nonfinancial liabilities and the adoption of such guidance did not have any effect on the Company’s financial statements. 

In June 2008, FASB issued guidance for determining whether an equity-linked financial instrument (or embedded feature) is indexed to an entity’s own stock, which would qualify as a scope exception to derivative classification under ASC Topic “Derivatives and Hedging”.  The guidance is effective for fiscal years beginning after December 15, 2008 and early adoption for an existing instrument is not permitted.  The Company adopted this guidance, effective August 1, 2009.  The adoption had no impact on the Company’s previously accounted for equity-linked financial instruments that were considered to be indexed to its own equity.  Refer to Note 6 for the result of the adoption on the equity-linked instruments included within the Securities Purchase Agreement entered into on October 19, 2009.

In August 2009, FASB issued amended guidance on the measurement of liabilities at fair value.  The guidance provides clarification that in circumstances in which a quoted market price in an active market for an identical liability is not available, the fair value of a liability be measured using one or more of the valuation techniques that uses the quoted price of an identical liability when traded as an asset or, if unavailable, quoted prices for similar liabilities or similar assets when traded as assets.  If none of this information is available, an entity should use a valuation technique in accordance with existing fair valuation principles.  This guidance is effective for the first reporting period (including interim periods) after issuance.  The Company adopted this guid ance in the quarter ended October 31, 2009.  The adoption had no impact on the Company’s financial statements.

 
F - 22

 
 
In October 2009, FASB issued amended guidance for separating consideration in multiple-deliverable arrangements.  It eliminates the requirement under previous guidance that all undelivered elements have vendor-specific objective evidence (VSOE) or third-party evidence (TPE) of fair value before recognizing a portion of revenue related to the delivered items, and establishes that revenue be allocated to each element based on its relative selling price, as determined by VSOE, TPE, or the entity’s estimated selling price if neither of the aforementioned is available.  Additionally, the amended guidance eliminates the residual method of allocation and expands required disclosures about multiple-element revenue arrangements.  It will be effective prospectively for revenue arrangements entered into beginning January 1, 2011, with early adoption permitted.  The Company is currently evaluating the impact that the adoption of this guidance will have, if any, on the Company’s financial statements.

In January 2010, the FASB issued a new guidance, Improving Disclosures about Fair Value Measurements (ASU 2010-06).  This provision amends previous provisions that require reporting entities to make new disclosures about recurring and nonrecurring fair value measurements including the amounts of and reasons for significant transfers into and out of Level 1 and Level 2 fair value measurements and separate disclosure of purchases, sales, issuances, and settlements in the reconciliation of Level 3 fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years beginning after December 15, 2009, except for Level 3 reconciliation disclosures which are effective for fiscal years, and interim periods within those fiscal years beginning after December 15, 2010.&# 160; The adoption of this guidance did not have a material impact on the Company’s results of operations or financial condition.

In April 2010, the FASB issued a new guidance Revenue Recognition – Milestone Method.  This provision provides guidance on the criteria that should be met for determining whether the milestone method of revenue recognition is appropriate.  A vendor can recognize consideration that is contingent upon achievement of a milestone in its entirety as revenue in the period in which the milestone is achieved only if the milestone meets all criteria to be considered substantive.  The following criteria must be met for a milestone to be considered substantive.  The consideration earned by achieving the milestone should 1) be commensurate with either the level of effort required to achieve the milestone or the enhancement of the value of the item delivered as a result of a specific outcome r esulting from the vendor’s performance to achieve the milestone; 2) related solely to past performance; 3) be reasonable relative to all deliverables and payment terms in the arrangement.  No bifurcation of an individual milestone is allowed and there can be more than one milestone in an arrangement.  Accordingly, an arrangement may contain both substantive and non substantive milestones.  This guidance is effective on a prospective basis for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010.  The adoption of this guidance does not have a material impact on the Company’s financial statements.

(2)
Liquidity

The Company has reported net losses of $14,187,000 and $4,539,000 and negative cash flows from operating activities of $2,824,000 and $4,542,000 for fiscal years ended July 31, 2010 and 2009, respectively.  As of July 31, 2010, the Company had net working capital deficit of $14,972,000, and cash and cash equivalents of $321,000.  The loss from date of inception, August 24, 1981, to July 31, 2010 amounts to $123,119,000.  Until and unless the Company’s operations generate significant revenues and cash flow, the Company will attempt to continue to fund operations from cash on hand and through the sources of capital described below.  The Company’s long-term continued operations will depend on its ability to raise additional funds through various potential sources such as equity and debt financing, convertible debentures, collaborative agreements, strategic alliances, sale of tax benefits, revenues from the commercial sale of ONCONASE®, licensing of its proprietary RNase technology and its ability to realize revenues from its technology and its drug candidates via out-licensing agreements with other companies.  The Company is also pursuing available strategic alternatives which focuses on, but not be limited to, strategic partnership transactions, and could include a possible sale of the Company.  Such additional funds and various alternatives may not become available as the Company may need them or be available on terms acceptable to the Company.  Insufficient funds could require the Company to delay, scale back, or eliminate one or more of its research and development programs or to license third parties to commercialize drug product candidates or technologi es that the Company would otherwise seek to develop without relinquishing its rights thereto.  The Company expects that its cash balances as of July 31, 2010 will be sufficient to support its activities through April 2011.  There can be no assurance that the Company will be able to raise the capital it needs on terms which are acceptable, if at all.  The Company may also obtain additional capital through the exercise of outstanding options and warrants and the sale of its tax benefit, although it cannot provide any assurance of such exercises or sale or the amount of capital it will receive, if any.

 
F - 23

 
 
The Company’s audited financial statements for the fiscal year ended July 31, 2010 were prepared under the assumption that the Company will continue its operations as a going concern.  Continued operations are dependent on the Company’s ability to raise various sources of capital described above.  Such capital formation activities may not be available or may not be available on reasonable terms.  The Company’s financial statements do not include any adjustments that may result from the outcome of this uncertainty.

(3)      Restricted Cash

Restricted cash is an escrow account held by a bank which can only disburse funds to satisfy obligations of the Company owed to clinical research organizations, hospitals, doctors and other vendors and service providers associated with the clinical trials which the Company intends to conduct for its ONCONASE® product. The escrow agreement governing the account shall terminate on the earlier of the date that all funds have been disbursed from the escrow account or April 19, 2011, at which time any remaining funds will be disbursed to the Company.
 
 (4)     Net Loss Per Common Share

The following table sets forth the computation of basic and diluted net loss per common share:

   
Year Ended July 31,
 
   
2010
   
2009
 
             
Numerator:
           
     Net loss
  $ (14,186,965 )   $ (4,539,396 )
Denominator:
               
Weighted average number of common shares outstanding
    47,313,000       47,313,000  
Loss per common share - basic and diluted
  $ (0.30 )   $ (0.10 )
Potentially dilutive securities:
               
     Warrants
    49,784,000       8,495,650  
     Convertible notes (principal & interest)
    22,503,651       -  
     Stock options
    3,535,467       4,771,650  
Total potentially dilutive securities
    75,823,118       13,267,300  

As the Company has incurred a net loss for all periods presented, basic and diluted per common share amounts are the same, since the inclusion of all potentially dilutive securities would be anti-dilutive.

 (5)
Property and Equipment

Property and equipment, at cost, consists of the following at July 31:
 
   
2010
   
2009
 
                 
Laboratory equipment
  $ 276,202     $ 276,202  
Office equipment
    111,049       118,172  
Leasehold improvements
    23,778       90,778  
 Less accumulated depreciation and amortization     (378,435     (377,134
Property and equipment, net   $ 32,594     $ 108,018  
 
 
F - 24

 
During the fiscal year ended July 31, 2010, the Company wrote off the following unusable property and equipment:

   
Cost
   
Accumulated Depreciation
   
Net Book
Value
 
                   
Office equipment
  $ 9,872     $ 4,442     $ 5,430  
Leasehold improvements
    67,000       16,616       50,384  
Total
  $ 76,872     $ 21,058     $ 55,814  

(6)      Convertible Notes and Warrants
 
On October 19, 2009, the Company completed a sale of 65 units (the “Units”) in a private placement (the “Offering”) to certain investors pursuant to a securities purchase agreement (the “Securities Purchase Agreement”).  Each Unit consists of (i) $50,000 principal amount of 5% Senior Secured Convertible Promissory Notes (collectively, the “Notes”) convertible into shares of the Company’s common stock, par value $.001 per share (“Common Stock”), (ii) Series A Common Stock Purchase Warrants (the “Series A Warrants”) to purchase in the aggregate that number of shares of Common Stock initially issuable upon conversion of the aggregate amount of Notes issued as part of the Unit, at an exercise price of $0.15 per share with a three year term and (iii) Series B Common Stock Purchase Warrants (the “Series B Warrants”, together with the Series A Warrants, the “Warrants”) to purchase in the aggregate that number of shares of Common Stock initially issuable upon conversion of the aggregate amount of Notes issued as part of the Unit, at an exercise price of $0.25 per share with a five year term. The closing of the Offering occurred on October 19, 2009 (the “Closing”) and the Company received an aggregate of $3,250,000 in gross proceeds.
 
The Notes mature on the earlier of (i) October 19, 2012; (ii) the closing of a public or private offering of the Company’s debt or equity securities subsequent to the date of issuance resulting in gross proceeds of at least $8,125,000 other than a transaction involving a stockholder who holds 5% or more of the Company’s outstanding capital stock as of the date of issuance; or (iii) on the demand of the holder of the Note upon the Company’s consummation of a merger, sale of substantially all of its assets, or the acquisition by any entity, person or group of 50% or more of the voting power of the Company.  Interest accrues on the principal amount outstanding under the Notes at 5% per annum, and is due upon maturity. Upon an event of default under the Notes, the interest rate shall increase to 7%.  On April 27, 2010, the stockholders approved an amendment to the certificate of incorporation increasing the number of authorized shares of capital stock of the Company to cover the conversion of the Notes and exercise of the Warrants.  The amendment was filed on the same date.  The Notes are convertible into Common Stock at the option of the holder of the Note at a price of $0.15 per share at any time prior to the date on which the Company makes payment in full of all amounts outstanding under the Note. The Notes are not prepayable for a period of one year following the issuance thereof.  The Notes are secured by a senior security interest and lien on all of the Company’s right, title and interest to all of the assets owned by the Company as of the Closing or thereafter acquired pursuant to the terms of a security agreement (the “Security Agreement”) entered into by the Company with each of the investors. The Warrants are exercisable immedia tely following the Closing.
 
In connection with the Offering, the Company entered into an investor rights agreement (the “Investor Rights Agreement”) with each of the investors.  The Investor Rights Agreement provides that the Company will file a “resale” registration statement (the “Initial Registration Statement”) covering all of the shares issuable upon conversion of the Notes (the “Note Shares”) and the shares issuable upon exercise of the Warrants (the “Warrant Shares”, together with the Note Shares, the “Securities”), up to the maximum number of shares able to be registered pursuant to applicable Securities and Exchange Commission (“SEC”) regulations, within 120 days of the Closing (the “Filing Deadline”).  On February 26, 2010, the C ompany and the investors amended the Investor Rights Agreement (the “Rights Agreement Amendment”) to extend the Filing Deadline to May 1, 2010, which Rights Agreement Amendment was filed with the Form 8-K filed by the Company on March 4, 2010.  In accordance with the Investor Rights Agreement, on April 30, 2010, the Company filed with the SEC a “resale” registration statement on Form S-1.  If any Securities are unable to be included on the Initial Registration Statement, the Company has agreed to file subsequent registration statements until all the Securities have been registered.  Under the terms of the Investor Rights Agreement, the Company is obligated to maintain the effectiveness of the “resale” registration statement until all securities therein are sold or otherwise may be sold by non-affiliates pursuant to Rule 144, without restrictions. A cash penalty at 1% per month will be triggered in the event the Company fails to file or ob tain the effectiveness of a registration statement prior to the deadlines set forth in the Investor Rights Agreement, which deadlines were extended by the Rights Agreement Amendment, or if the Company ceases to be current in filing its periodic reports with the SEC.  The aggregate penalty accrued with respect to each investor may not exceed 6% of the original purchase price paid by that investor, or 12% if the only effectiveness failure is the Company’s failure to be current in its periodic reports with the SEC.
 
On July 31, 2010, the Company entered into a second amendment to the Investor Rights Agreement with the investors, pursuant to which the investors waived their right to receive penalties in respect of all matters occurring prior to the date of the second amendment, which included the Company’s failure to obtain the effectiveness of a registration statement within the deadlines set forth in the Investor Rights Agreement. In addition, the second amendment postponed the investors right to require the Company to file a "resale" registration statement covering all of the shares issuable upon conversion of the Senior Secured Notes and the shares issuable upon exercise of the Warrants until after the Company’s next financing which yields gross proceeds of at least $3,250,000. In the event of such a financing, a nd following a written demand made by the holders of the majority of the registrable securities, the Company must file, within 90 days of its receipt of the demand notice, either a new "resale" registration statement registered the shares or amend the registration statement the Company filed on April 30, 2010.
 
 
F - 25

 
 
In connection with the Offering, the Company also entered into an escrow agreement (the “Escrow Agreement”) whereby certain investors placed $1,600,000 of the proceeds paid for their Units in an escrow account pursuant to the terms of the Securities Purchase Agreement.  Such amounts can be disbursed from the escrow account only to satisfy obligations of the Company owed to clinical research organizations, hospitals, doctors and other vendors and service providers associated with the clinical trials which the Company intends to conduct for its ONCONASE® product. The Escrow Agreement shall terminate on the earlier of the date that all funds have been disbursed from the escrow account and April 19, 2011, at which t ime any remaining funds will be disbursed to the Company.

Charles Muniz, the Company’s President, Chief Executive Officer and Chief Financial Officer, subscribed for 20 Units; certain trusts and individuals related to James O. McCash, a beneficial owner of more than five percent of the Company’s voting securities, subscribed for an aggregate of 20 Units; Europa International Inc., a beneficial owner of more than five percent of the Company’s voting securities, subscribed for 15 Units; and Unilab LP, an affiliate of US Pharmacia, an affiliate of the Company’s distributor for ONCONASE® in Eastern Europe and a current stockholder, subscribed for 10 units. These investors are party to the Securities Purchase Agreement, the Investor Rights Agreement, the Security Agreemen t and the Escrow Agreement. The Company’s entry into an employment agreement with Mr. Muniz upon terms reasonably acceptable to the investors in the Offering was a condition to the Closing.

The Company concluded that it should account for the warrants and conversion options embedded in the Notes in accordance with ASC Topic “Derivatives and Hedging”.  Accordingly, the Company determined that the warrants and the conversion options embedded in the Notes should be accounted for as free standing derivatives that will be measured at fair value and classified as liabilities at the closing of the Offering.  Each subsequent reporting period, the Company will mark to market the warrants and conversion feature of Notes with any change in fair value recorded through the statement of operations.  This accounting treatment is due to the fact that the settlement terms of the warrants and conversion feature of the Notes do not allow them to qualify for equity presentation du e to down-round protection.  Accordingly, on October 19, 2009, in connection with the closing of the Offering, the convertible feature of the Notes were recorded as a derivative liability of approximately $6.1 million and the Series A and Series B warrants were recorded as a derivative liability of approximately $6.1 million each, respectively.

At the closing for the Offering, the fair value of the conversion feature, approximately $6.1 million, exceeded the proceeds of $3.25 million. The difference of approximately $2.9 million was charged to expense as the change in the fair market value of the conversion liability. Accordingly, the Company recorded an initial discount of $3.25 million equal to the face value of the Notes, which will be amortized over the three-year term, using the straight-line method.
   
At July 31, 2010, the Company accounted for the conversion feature using the fair value method, with the resultant gain recognition recorded in the statement of operations. At July 31, 2010, the fair value of the conversion feature liability was approximately $5.2 million, comprised of the $6.1 million recorded at the closing for the Offering and $0.9 million gain recorded to mark to market the liability at July 31, 2010. The conversion feature was valued at October 19, 2009 and July 31, 2010 using the Black-Scholes valuation model and the following assumptions:
 
 
October 19, 2009
 
July 31, 2010
       
Volatility
126%
 
153.71%
Risk-free interest rate
1.50%
 
0.55%
Remaining contractual life (years)
3.0
 
2.22

At the Closing, the Company recorded the Series A and Series B warrants as liabilities at their fair values of approximately $6.1 million each, based upon the Black-Scholes valuation model.  The warrants will be accounted for using mark-to-market accounting and charged to the statement of operations in a manner similar to the conversion feature at each reporting date.
     
At July 31, 2010, the Company accounted for the warrant liabilities using the fair value method, with the resultant gain recognition recorded in the statement of operations.  At July 31, 2010, the fair value of the Series A and Series B warrant liabilities were approximately $5.2 million and $5.1 million, respectively.  The fair value of the Series A warrant is comprised of the $6.1 million recorded at the closing for the Offering and approximately $0.9 million gain recorded to mark to market the liability at July 31, 2010.  The fair value of the Series B warrant is comprised of the $6.1 million recorded at the closing for the Offering and approximately $1.0 million gain recorded to mark to market the liability at July 31, 2010.

 
F - 26

 
 
The Series A and Series B warrant liabilities were valued at October 19, 2009 and July 31, 2010 using the Black-Scholes valuation model and the following assumptions:

 
Series A Warrants
 
Series B Warrants
 
October 19, 2009
 
July 31, 2010
 
October 19, 2009
 
July 31, 2010
               
Volatility
126%
 
153.71%
 
113.17%
 
123.44%
Risk-free interest rate
1.50%
 
0.55%
 
2.36%
 
1.22%
Remaining contractual life (years)
3.0
 
2.22
 
5.0
 
4.22

In addition, the Company evaluated the classification of all non-employee share commitments issued outside of the plans which existed prior to the Offering (the “Prior Non-Employee Commitments”). As a result, at October 19, 2009, the Company reclassified $747,235 from equity to liability for all Prior Non-Employee Commitments and has included this amount as a part of derivative liability.  The Company marked to market the Prior Non-Employee Commitments at April 27, 2010 and recorded a gain of $611,085 for the change in fair value from October 19, 2009 to April 27, 2010.  On April 27, 2010, the Company’s stockholders approved an amendment to the Company’s certificate of incorporation increasing the amount of authorized shares to cover all existing share commitments therefor e, the marked-to-market liabilities for Prior Non-Employee Commitments were reclassified to equity in the amount of $136,150.

(7)      Stockholders' Equity
 
On September 1, 1981, the Company issued 712,500 shares of common stock (1,068,750 shares adjusted for the stock split on September 8, 1982) to officers and stockholders in exchange for equipment, research and development services, stock registration costs, reimbursement of expenses and other miscellaneous services.  The common stock issued for services was recorded at the estimated fair value of services rendered based upon the Board of Directors' determination and ratification of the value of services.  Equipment received in exchange for common stock was recorded at the transferor's cost.  Common stock issued for reimbursement of expenses was recorded based upon expenses incurred.  All values assigned for expenses and services rendered were charged to operations except for stock registration costs, which were charged against proceeds.

On July 30, 1982, the Company sold 82,143 shares of common stock (123,214 shares adjusted to reflect the stock split on September 8, 1982) to a private investor at a price of $1.40 per share, resulting in net proceeds to the Company of approximately $108,500.

On September 8, 1982, the Company declared a 3-for-2 stock split.  Shares previously issued by the Company were restated in accordance with the stock split.

On September 8, 1982, the Company issued 15,000 shares of common stock to an officer and stockholder in exchange for equipment.  The equipment received in exchange for the common stock was recorded at the transferor's cost.

On November 1, 1982 and January 3, 1983, the Company sold 28,125 and 16,071 shares of common stock, respectively, to private investors at $.93 per share, resulting in net proceeds to the Company of approximately $41,250.

On January 17, 1983, the Company sold 660,000 shares of its common stock and 330,000 common stock purchase warrants in a public offering at a price of $2.50 per share, resulting in net proceeds to the Company of approximately $1,308,446.  The warrants were to expire 12 months after issuance; however, the Company extended the expiration date to July 16, 1984.  During the fiscal years ended July 31, 1983 and 1984, the net proceeds to the Company from the exercise of the warrants amounted to $934,000.  Each common stock purchase warrant was not detachable from its common stock or exercisable until six months after the issuance date of January 17, 1983.  Each warrant entitled the holder to purchase one share of common stock at an exercise price of $3.00 after six months and prior to nine months after issuance.  The exercise price increased to $3.50 after nine months and prior to 12 months after issuance.

 
F - 27

 
 
In connection with the public offering, the Company sold 60,000 five-year purchase warrants to the underwriters at a price of $.001 per warrant.  Each warrant entitled the holder to purchase one share of common stock at an exercise price of $3.00.  Pursuant to the antidilution provisions of the warrants, the underwriters received warrants to purchase 67,415 shares at an exercise price of $2.67 per share.  By July 31, 1986, all such warrants were exercised and the Company received proceeds of approximately $180,000.

On February 22, 1984, the Company filed a registration statement with the Securities and Exchange Commission for the issuance of two series of new warrants, each to purchase an aggregate of 330,000 shares (hereinafter referred to as one-year warrants and two-year warrants).  The one-year warrants had an exercise price of $6.50 per share and expired July 17, 1985.  The two-year warrants had an exercise price of $10.00 per share and were to expire July 17, 1986.  However, the Company extended the expiration date to August 31, 1987.  The one-year warrants and two-year warrants were issued as of July 17, 1984 on a one-for-one basis to those public offering warrant holders who exercised their original warrants, with the right to oversubscribe to any of the warrants not exercised.&# 160; During the fiscal years ended July 31, 1985, 1986, 1987 and 1988, the Company received net proceeds of approximately $2,471,000 as a result of the exercise of the warrants.

On January 2, 1987, the Company issued 250,000 shares of common stock to officers and stockholders, including the President and Chief Executive Officer, in recognition of services performed for the Company.  The fair value of such shares was recorded as compensation expense.

On February 3, 1987, the Company sold 5,000 shares of common stock to a private investor for $5.00 per share, resulting in net proceeds to the Company of approximately $25,000.

On September 1, 1987, the Board of Directors approved new wage contracts for three officers.  The contracts provided for the issuance of 700,000 shares of common stock as an inducement for signing.  The fair value of these shares was recorded as deferred compensation and was amortized over the term of the employment agreements.  The contracts also provided for the issuance of 1,500,000 shares of common stock in 750,000 increments upon the occurrence of certain events.  These shares were issued during the fiscal years ended July 31, 1989 and 1990 and the fair value of such shares was recorded as deferred compensation and was amortized over the remaining term of the employment agreements.  The contracts also provided for five-year options to purchase 750,000 shares of common stock at $3.00 per share; options for the purchase of 170,000 shares were exercised on June 16, 1988 and the remaining options for the purchase of 580,000 shares expired on September 2, 1992.

During the fiscal year ended July 31, 1988, the Company issued 206,429 shares of common stock for payment of legal and consulting services.  The Company also issued 12,500 shares of common stock in connection with the settlement of certain litigation.  The fair value of such shares was charged to operations.

During the fiscal year ended July 31, 1988, the Company sold 61,073 shares of common stock to private investors at $2.92 per share resulting in net proceeds to the Company of approximately $178,133.

On September 21, 1988, the Company entered into a stipulation of settlement arising from a lawsuit wherein it agreed to pay a total of $250,000 in 12 monthly installments.  Under the agreement, the Company authorized the issuance on September 7, 1988 and October 18, 1988 of 85,000 and 50,000 shares, respectively, to an escrow account to secure payment of the $250,000 due under the stipulation of settlement.  During the fiscal year ended July 31, 1989, the Company issued and sold the 135,000 shares of common stock for $1,074,838.  On February 14, 1989, the Board of Directors authorized the issuance of an additional 50,000 shares.  During the year ended July 31, 1990, the shares were sold for $351,117.  The proceeds from the above transactions were used to pay the sett lement and related legal costs, reduce loans from and interest due to the Company's Chief Executive Officer, and for working capital.
 
During the fiscal year ended July 31, 1989, the Company sold 105,840 shares of common stock to private investors at $3.97 per share resulting in net proceeds to the Company of approximately $420,000.

During the fiscal year ended July 31, 1990, the Company issued 52,463 shares of common stock for payment of legal and consulting services and 50,000 shares of common stock in connection with the settlement of certain litigation.  The fair value of the common stock was charged to operations.

 
F - 28

 
 
During the fiscal year ended July 31, 1990, the Company sold 89,480 shares of common stock to private investors at $3.97 per share resulting in net proceeds to the Company of approximately $355,080.

During the fiscal year ended July 31, 1991, the Company issued 87,000 shares of common stock for payment of legal and consulting services.  The fair value of the common stock was charged to operations.

During the fiscal year ended July 31, 1992, the Company sold 70,731 shares of common stock to private investors at $2.75 to $3.50 per share resulting in net proceeds to the Company of approximately $219,900.

During the fiscal year ended July 31, 1992, the Company issued 45,734 shares of common stock as payment for services rendered to the Company.  The fair value of the common stock was charged to operations.

During the fiscal years ended July 31, 1992 and 1990, 94,000 and 50,000 shares of common stock, respectively, were issued to the Company's Chief Executive Officer upon the conversion of outstanding debentures.
 
During the fiscal year ended July 31, 1993, the Company sold 352,667 shares of common stock to private investors at prices ranging from $2.00 to $3.00 per share resulting in net proceeds to the Company of approximately $735,500.  In addition, the private investors were granted options to purchase common stock totaling 587,167 shares at prices ranging from $3.00 to $7.00.  During the fiscal years ended July 31, 1995 and 1996, 322,500 and 228,833 options expired, respectively.  A total of 42,167 options due to expire on July 31, 1995 were extended to July 31, 1996 and their exercise price was reduced to $2.50.  During the fiscal year ended July 31, 1996, 35,834 options were exercised resulting in net proceeds to the Company of approximately $89,600.

During the fiscal year ended July 31, 1993, the Company issued 54,600 shares of common stock as payment for legal and other services performed for the Company.  The fair value of 49,600 shares was charged to operations.  The remaining 5,000 shares were recorded as deferred compensation and were amortized over a one-year period, beginning in February 1993, in accordance with the agreement entered into with the recipient.

During the fiscal year ended July 31, 1994, the Company issued 7,000 shares of common stock as payment for services performed for the Company.  The fair value of the common stock was charged to operations.
 
During the fiscal year ended July 31, 1994, the Company sold 25,000 shares of common stock to a private investor at $2.00 per share resulting in net proceeds to the Company of $50,000.  In addition, the private investor was granted options to purchase common stock totaling 25,000 shares at $4.00 per common share.  These options were exercised in September 1996 resulting in net proceeds to the Company of $100,000.

During the fiscal year ended July 31, 1994, the Company sold 800,000 shares of common stock to private investors at $2.50 per share resulting in net proceeds to the Company of $1,865,791.  In addition, the private investors were granted warrants to purchase common stock totaling 800,000 shares at $5.00 per common share. Warrants for the purchase of 147,450 shares were exercised during fiscal 1997 resulting in net proceeds to the Company of $737,250.  The remaining 652,550 warrants expired during fiscal 1997.

During the fiscal year ended July 31, 1994, 400,000 shares of common stock were issued to the Company's Chief Executive Officer upon the conversion of outstanding debentures.
 
During the fiscal year ended July 31, 1994, 25,400 shares of common stock were issued upon the conversion of other outstanding debentures.

In September 1994, the Company completed a private placement resulting in the issuance of 288,506 shares of common stock and three-year warrants to purchase 288,506 shares of common stock at an exercise price of  $5.50 per share.  The warrants expired during fiscal 1998.  The common stock and warrants were sold in units consisting of 20,000 shares of common stock and warrants to purchase 20,000 shares of common stock.  The price per unit was $50,000.  The Company received proceeds of approximately $545,000, net of costs associated with the placement of approximately $55,000 and the conversion of certain debt by creditors of $121,265 into equivalent private placement units of 17,600 shares for conversion of short-term borrowings and 30,906 shares issued for services r endered.  In October 1994, an additional two units at $50,000 per unit were sold to a private investor under the same terms as the September 1994 private placement resulting in the issuance of 40,000 shares of common stock and warrants to purchase 40,000 shares of common stock.  The warrants expired during fiscal 1998.

 
F - 29

 
 
During the fiscal year ended July 31, 1995, 185,000 shares of common stock were issued upon the exercise of stock options by unrelated parties, resulting in net proceeds to the Company of $437,200.  The exercise prices of the options ranged from $2.27 to $2.50, which had been reduced from $3.50 and $5.00, respectively, during fiscal 1995.

During the fiscal year ended July 31, 1995, the Company sold 681,000 shares of common stock to private investors resulting in net proceeds to the Company of approximately $1,379,000.  The shares were sold at prices ranging from $2.00 to $2.25.

During the fiscal year ended July 31, 1995, the Company sold 139,080 shares of common stock and 47,405 three-year warrants to purchase shares of common stock at an exercise price of $4.00 per share to private investors.  The stock and warrants were sold at prices ranging from $2.25 to $2.73 per share and resulted in net proceeds to the Company of $343,808, of which $4,800 was for services rendered.  The common shares were issued to the investors subsequent to July 31, 1995.

On August 4, 1995, the Company issued 6,060 shares of common stock as payment for services rendered to the Company.  The fair value of the common stock was charged to operations.

On September 29, 1995, the Company completed a private placement resulting in the issuance of 1,925,616 shares of common stock and three-year warrants to purchase an aggregate of 55,945 shares of common stock at an exercise price of $4.00 per share.  Of these shares 1,935 were issued for services rendered to the Company.  The common stock was sold alone at per share prices ranging from $2.00 to $3.70, and in combination with warrants at per unit prices ranging from $4.96 to $10.92, which related to the number of warrants contained in the unit.  The Company received proceeds of approximately $4.1 million, including $1,723,000 for approximately 820,000 shares received during the fiscal year ended July 31, 1995.  The warrants expired in October 1998.

As consideration for the extension of the Company's term loan agreement with its bank, the Company granted the bank a warrant to purchase 10,000 shares of common stock at an exercise price of $4.19.  The warrants were issued as of October 1, 1995 and expired on August 31, 1997.

In June 1996, the Company sold in a private placement 1,515,330 shares of common stock and three-year warrants to purchase 313,800 shares of common stock at an exercise price of $7.50 per share.  Of these shares, 12,000 were issued for services rendered to the Company.  The common stock was sold alone at a per share price of $3.70, in combination with warrants at a per unit price of $12.52 and warrants were sold alone at a per warrant price of $1.42.  Each unit consisted of three shares of common stock and one warrant.  The Company received proceeds of approximately $5.7 million.  The warrants expired during the fiscal year 2000.

In June 1996, the Company issued 10,000 five-year stock options as payment for services rendered.  The options vested immediately and had an exercise price of $4.95 per share.  The Company recorded research and development expense of $28,260, which was the fair value of the stock options on the date of issuance.  The options expired during the fiscal year ended July 31, 2001.

During the fiscal year ended July 31, 1996, 207,316 shares of common stock were sold from October 1995 to April 1996 at per share prices ranging from $3.60 to $4.24 resulting in proceeds of approximately $808,000.

During the fiscal year ended July 31, 1996, 656,334 stock options were exercised by both related and unrelated parties resulting in net proceeds of approximately $1.9 million to the Company.  Of these shares, 89,634 were issued subsequent to July 31, 1996.  The exercise prices of the options ranged from $2.50 to $3.87 per share.

In August 1996, the Company issued 10,000 stock options with an exercise price of $4.69 per share exercisable for five years as payment for services to be rendered.  An equal portion of these options vested monthly for one year commencing September 1, 1996.  The Company recorded general and administrative expense of $27,900, which was the fair value of the stock options on the date of issuance.  The options expired during the fiscal year ended July 31, 2002.

 
F - 30

 
 
In March 1997, the Company issued 112,000 shares of common stock at $4.50 per share in a private placement to an investor resulting in net proceeds of $504,000 to the Company.

In May 1997, the Company issued 100,000 stock options to Dr. Stephen Carter, a director, with an exercise price of $5.20 per share as payment for serving as Chairman of the Scientific Advisory Board (the “SAB”).  These options vested as follows: 10,000 vested immediately, 10,000 after one full calendar year, 10,000 annually for each of the following three years and 50,000 on May 13, 2002.  The Company recorded a total research and development expense of $353,400, which was the fair value on the date of issuance of that portion of the stock options that had vested as of July 31, 2002.  Of these options, 40,000 expired as of the fiscal year ended July 31, 2005.

During the fiscal year ended July 31, 1997, 639,500 stock options were exercised by both related and unrelated parties resulting in net proceeds of approximately $2.6 million to the Company.  The exercise prices of the options ranged from $2.45 to $4.00 per share.

During the fiscal year ended July 31, 1997, 147,450 warrants were exercised by both related and unrelated parties resulting in net proceeds of approximately $737,250 to the Company.  The exercise price of the warrants was $5.00 per share.

In October 1997, the Company issued 75,000 stock options to a director with an exercise price of $3.66 per share as payment for non-board related services to be rendered.  These options vested as follows:  10,000 vested immediately; 10,000 after one full calendar year; 10,000 annually for each of the following three years; and 25,000 on October 31, 2002.   A total general and administrative expense of $185,600 was amortized on a straight –line basis over a five-year period, which commenced in October 1997.  Of these options, 30,000 expired as of the fiscal year ended July 31, 2005.

In October 1997, the Company issued 12,000 five-year stock options to a consultant with an exercise price of $3.91 per share as payment for services to be rendered.  An equal portion of these options vested monthly and were amortized over a one-year period which commenced in October 1997.  In May 1998, the Company terminated the services of the consultant, which resulted in the cancellation of 5,000 options.  The Company recorded a total research and development expense for the remaining 7,000 options in the amount of $15,800, based upon the fair value of such options on the date of issuance, amortized on a straight-line basis over the vesting period of the grant.  These options expired during the fiscal year ended July 31, 2003.

On December 9, 1997, the stockholders authorized the amendment of the Company’s Certificate of Incorporation to increase the number of authorized shares of common stock, par value $.001 from 25,000,000 shares to 40,000,000 shares.

On December 9, 1997, the stockholders approved the 1997 Stock Option Plan (the “1997 Plan”).  The total number of shares of common stock authorized for issuance upon exercise of options granted under the 1997 Plan was 2,000,000.  Options are granted at fair market value on the date of the grant and generally are exercisable in 20% increments annually over five years starting one year after the date of grant and terminate five years from their initial exercise date.

On January 23, 1998, the SEC declared effective a registration statement on Form S-3 for the offer and sale by certain stockholders of up to 3,734,541 shares of common stock.  Of these shares (i) an aggregate of 2,737,480 shares were issued to private placement  investors in private placement transactions which were completed during the period from March 1994 through March 1997 (the “Earlier Private Placements”), (ii) an aggregate of 409,745 shares were issuable upon exercise of warrants which were issued to private placement investors in the Earlier Private Placements and (iii) an aggregate of 587,316 shares may be issued, or have been issued, upon exercise of options which were issued to option holders in certain other private transactions.  As a result of the delisting of the Company’s Common Stock from the Nasdaq SmallCap Market, the Company no longer qualified for the use of a Form S-3 registration statement for this offering when it filed its annual report on Form 10-K for the fiscal year ended July 31, 1999 and thus, this registration statement was no longer effective. The Company filed a registration statement on Form S-1 to register these shares, which was declared effective in February 2002.

 
F - 31

 
 
In February 1998, the Company completed a Private Placement primarily to institutional investors, which resulted in the issuance of 1,168,575 units at a unit price of $4.00.  Each unit consisted of two (2) shares of the Company’s common stock, par value $.001 per share and one (1) three-year warrant to purchase one (1) share of common stock at an exercise price of $2.50 per share.  The Company received net proceeds of approximately $4,202,000.  The placement agent received warrants to purchase an additional 116,858 units comprised of the same securities sold to investors at an exercise price of $4.40 per unit as part of its compensation.  In May 2001, the expiration date of these warrants was extended from May 19, 2001 to August 17, 2001.  The warrants expired on August 17, 2001.

In March 1998, the Company converted an outstanding payable into 50,000 shares of the Company’s Common Stock.  The fair value of the Common Stock approximated the outstanding payable amount of $100,000.

In March 1998, the Company issued 75,000 stock options to a director with an exercise price of $2.80 per share as payment for non-board related services rendered.  These options vested as follows: 10,000 vested immediately; 10,000 after one full calendar year; 10,000 annually for each of the following three years; and 25,000 on March 24, 2003.  A total general and administrative expense of $138,100 was amortized on a straight-line basis over a five-year period, which commenced in March 1998.  As of July 31, 2003, the expense was fully amortized and recorded, based upon the fair value of such 75,000 options on the date of issuance, amortized on a straight-line basis over the vesting period of the grant.  Of these options, 10,000 expired during the fiscal year ended July 31, 200 3 and 65,000 were exercised during the fiscal year ended July 31, 2004.

On April 20, 1998 the SEC declared effective a registration statement on Form S-3 for the offer and sale by certain stockholders of up to 3,918,299 shares of common stock.  Of these shares (i) an aggregate of 2,337,150 shares of common stock were issued to the private placement investors in the February 1998 Private Placement, (ii) an aggregate of 1,168,575 shares may be issued upon exercise of the Warrants which were issued to the private placement investors in the February 1998 Private Placement, (iii) 350,574 shares may be issued upon the exercise of the Placement Agent Warrant which was issued to the placement agent in the February 1998 Private Placement and the Warrants issuable upon exercise of the Placement Agent Warrant, (iv) 50,000 shares of common stock were issued to a Supplier in connection wit h conversion of an outstanding accounts payable, and (v) 12,000 shares may be issued upon the exercise of options which were issued as payment for services to be rendered.  As a result of the delisting of the Company’s common stock from the Nasdaq SmallCap Market, the Company no longer qualified for the use of a Form S-3 registration statement for this offering when it filed its annual report on Form 10-K for the fiscal year ended July 31, 1999 and thus, this registration statement was no longer effective. The Company filed a registration statement on Form S-1 to register these shares, which was declared effective in February 2002.

During the fiscal year ended July 31, 1998, the Company issued 833 three-year stock options as payment for services rendered in August 1997.  The options vested thirty days from the issuance date and had an exercise price of $4.47 per share.  The total general and administrative expense recorded for these options was $1,700, based upon the fair value of such options on the date of issuance.  These options expired in August 2000.

During the fiscal year ended July 31, 1998, the Company issued 15,000 three-year stock options with an exercise price of $4.15 per share as payment for services.  An equal portion of these options vested monthly and a total general and administrative expense of $30,000 was amortized over a one-year period which commenced September 1997.  The Company also issued 5,000 three-year stock options with an exercise price of $4.15 per share as payment for services.  Of these options, 833 vested monthly for five months commencing September 30, 1997 and 835 vested on the last day of the sixth month.  Total general and administrative expense of $9,700 was amortized over a six-month period which commenced September 1997.  As of July 31, 1998, the Company recorded general and adm inistrative expense of $37,100, based upon the fair value of the 20,000 stock options on the date of the issuance, amortized on a straight-line basis over the vesting periods of the grants.  These options expired three years after they vested.

During the fiscal year ended July 31, 1998, 4,950 shares of common stock were issued upon the exercise of warrants by unrelated parties, resulting in net proceeds of approximately $11,100 to the Company.  The exercise prices of the warrants ranged from $2.20 to $2.50 per share.

On October 1, 1998 (the “Effective Date”), the Company entered into an agreement with a consultant (the “Agreement”), resulting in the issuance of 200,000 five-year stock options with an exercise price of $1.00 per share as payment for services to be rendered.  These options vested as follows: an aggregate of 20,000 vested on October 1, 1999; an aggregate of 2,500 of such options vested on the last day of each month over the first twelve months after the Effective Date of the Agreement; the remaining 150,000 options vested on the third anniversary of the Effective Date of the Agreement. The Company recorded approximately $49,300 of general and administrative expense based upon the fair value of the vested options through July 31, 2000.   During the fiscal year ended J uly 31, 2000, the Agreement was terminated which resulted in the cancellation of 150,000 options.  The remaining 50,000 options were exercised during the fiscal year ended July 31, 2004, which resulted in gross proceeds of $50,000 to the Company.
 
 
F - 32

 
 
During the fiscal year ended July 31, 1999, the Company issued 5,000 three-year stock options as payment for services rendered.  The total general and administrative expense recorded for these options was $4,200, based upon the fair value of such options on the date of issuance.  These options were exercised during the fiscal year ended July 31, 2000, which resulted in gross proceeds of $7,150 to the Company.

During the fiscal year ended July 31, 1999, the Company issued 40,701 shares of common stock for payment of legal services.  The fair value of the common stock in the amount of $16,631 was charged to operations.

During the fiscal year ended July 31, 1999, the Company issued 6,000 shares of common stock for payment of services rendered.  The fair value of the common stock in the amount of $2,460 was charged to operations.

During the fiscal year ended July 31, 2000, the Company issued 174,965 shares of common stock for payment of services rendered.  The fair value of the common stock in the amount of $92,184 was charged to operations.

During the fiscal year ended July 31, 2000, the Company issued 95,000 shares of common stock upon the exercise of stock options by unrelated parties, which resulted in gross proceeds of $45,850 to the Company.  The exercise prices of the options ranged from $0.43 to $1.43.

During the fiscal year ended July 31, 2000, the Company sold an aggregate of 875,000 shares of common stock to private investors at prices ranging from $0.50 to $1.00 per share resulting in net proceeds of $548,300 to the Company.  In addition, the private investors were granted warrants to purchase an aggregate of 875,000 shares of common stock, inclusive of additional warrants issued so that all investors in the private placements received substantially the same securities, at per share exercise prices ranging from $1.03 to $4.55.  These warrants expired in May 2003 and May 2005.

During the fiscal year ended July 31, 2001, the Company issued 11,800 shares of common stock for payment of services rendered.  The fair value of the common stock in the amount of $10,030 was charged to operations.

During the fiscal year ended July 31, 2001, the Company sold an aggregate of 863,331 shares of common stock to private investors at prices ranging from $0.90 to $1.50 per share resulting in net proceeds of $956,000 to the Company.  In addition, the private investors were granted warrants to purchase an aggregate of 696,665 shares of common stock at per share exercise prices ranging from $1.50 to $3.00.  The warrants will expire during the period commencing July 2004 and ending in October 2006.  Of these warrants, 418,887 expired and 277,778 were exercised.

During the fiscal year ended July 31, 2001, the Company issued 165,555 shares of common stock upon the exercise of stock options by related parties, which resulted in gross proceeds of $83,700 to the Company.  The per share exercise prices of the options ranged from $0.29 to $0.85.

During the fiscal year ended July 31, 2001, the Company issued 50,000 five-year stock options to a director as payment for non-board related services.  These options vested immediately and had an exercise price of $0.90 per share.  The Company recorded general and administrative expense of $31,600, which was the fair market value of the options using the Black-Scholes options-pricing model on the date of issuance.  These options were exercised during the fiscal year ended July 31, 2004.

During the fiscal year ended July 31, 2001, the Company issued 330,000 shares of common stock upon the conversion of convertible notes from related parties at $0.90 per share.  In addition, upon conversion, the related parties were granted three-year warrants to purchase an aggregate of 330,000 shares of common stock at an exercise price of $2.50 per share.  The estimated value of these warrants in the amount of $108,900 was recorded by the Company as interest expense during the fiscal year ended July 31, 2001.  In October 2001, the board of directors approved a change of the 330,000 warrants from three-year warrants to five-year warrants and the exercise price from $2.50 per share to $1.50 per share to conform with private placements to unrelated parties.  These warrants were exercised as of July 31, 2006.

 
F - 33

 
 
During the fiscal year ended July 31, 2002, the Company issued 72,214 shares of common stock upon the conversion of convertible notes from unrelated parties at $0.90 per share.  In addition, upon conversion, the unrelated parties were granted five-year warrants to purchase an aggregate of 72,214 shares of common stock at an exercise price of $1.50 per share.  The estimated value of these warrants in the amount of $32,200 was recorded by the Company as interest expense during the fiscal year ended July 31, 2002.  These options were exercised during the fiscals years ended July 31, 2007 and 2006.

During the fiscal year ended July 31, 2002, the Company issued 78,340 shares of common stock in settlement of accounts payable in the amount of $64,126.  In addition, one of the vendors was granted five-year warrants to purchase 55,556 shares of common stock at an exercise price of $1.50 per share.  The settled accounts payable amount was credited to equity as the value of the common stock and warrants.

During the fiscal year ended July 31, 2002, the Company issued an aggregate of 85,221 five-year stock options as payment for services rendered.  The options vested immediately and had a per share exercise prices of $0.75 as to 70,000 stock options and $0.94 as to 15,221 stock options.  The Company recorded an aggregate total of $40,747 non-cash expenses for these options, based upon the fair value on the date of the issuance as estimated by the Black-Scholes options-pricing model.  These options were exercised as of July 31, 2005.

During the fiscal year ended July 31, 2002, the Company sold an aggregate of 2,622,122 shares of common stock to private investors at prices ranging from $0.35 to $0.90 per share resulting in net proceeds of $1,050,000 to the Company.  In addition, the private investors were granted warrants to purchase an aggregate of 2,673,422 shares of common stock at per share exercise prices ranging from $0.75 to $1.50.  The warrants will expire during the period commencing August 2006 and ending in September 2007.   As of July 31, 2008, 1,733,638 of these warrants were exercised and 939,784 warrants expired.

During the fiscal year ended July 31, 2002, the Company issued warrants to purchase 1,500,000 shares of common stock to Roan Meyers Associates L.P. for an aggregate warrant purchase price of $1,500 in connection with the engagement of Roan Meyers to render advisory services.  Of these warrants, 250,000 were exercisable at $.50 per share, 650,000 were exercisable at $1.00 per share and 600,000 were exercisable at $1.50 per share.  In February 2002, the Company recorded an expense equal to the fair market value of the first 500,000 warrants which vested immediately, based upon the fair value of such warrants as estimated by Black-Scholes pricing model ($153,300), less the $1,500 received from the sale of the warrants.  The remaining 1,000,000 warrants were to become exercisable if Roan Me yers was successful in helping the Company raise capital.  However, Roan Meyers was not successful in raising additional capital from a third party.  During the fiscal year ended July 31, 2002, Roan Meyers exercised warrants to purchase an aggregate of 186,000 shares of common stock, at an exercise price of $0.50 per share, resulting in aggregate gross proceeds of $93,000 to the Company.  During the fiscal year ended July 31, 2003, the vesting of the 600,000 warrants was amended to vest immediately and the exercise price was amended from $1.50 to $0.50 per share due to the price change of the Company’s common stock.  Roan Meyers exercised these warrants and was issued 600,000 shares of common stock.  The Company also issued 40,000 shares of common stock upon the exercise of warrants by Roan Meyers at an exercise price of $.50 per share.  The Company realized aggregate gross proceeds of $320,000 from these capital raising transactions.  60;During the fiscal year ended July 31, 2004, the exercise price of 250,000 warrants was amended from $1.00 to $0.50 per share due to the price change of the Company’s common stock and the vesting of the 400,000 warrants was amended to vest immediately.  Roan Meyers exercised the remaining 674,000 warrants which resulted in the issuance of 674,000 shares of common stock by the Company.  The Company realized gross proceeds of $537,000 in this capital raising transaction.

During the fiscal year ended July 31, 2002, the Company issued an aggregate of 75,000 five-year stock options to unrelated parties as an incentive for lending the Company an aggregate of $75,000, which was repaid during the quarter.  The options vested immediately and have an exercise price of $1.50 per share.  The total non-cash interest expense recorded for these options was $25,615, based upon the fair value of such option on the date of issuance as estimated by the Black-Scholes options-pricing model.  Of these options, 25,000 were exercised and 50,000 expired.

 
F - 34

 
 
During the fiscal year ended July 31, 2002, the Company issued a note payable to an unrelated party in an aggregate amount of $300,000.  The note was due in thirty days bearing interest at 8% per annum.  In addition, the lender received warrants to purchase 300,000 shares of common stock at an exercise price of $0.60 per share.  The total non-cash interest expense recorded for these warrants was $40,690, based upon the fair value of such option on the date of issuance as estimated by the Black-Scholes options-pricing model.  The notes were extended for eighteen months at a conversion price of $0.40 per share plus a five-year warrant for each share of the Company’s common stock issued upon conversion at an exercise price of $1.00 per share.  These notes were con verted into shares of the Company’s common stock and warrants in fiscal year 2004.

During the fiscal year ended July 31, 2003, the Company issued an aggregate of 764,000 shares of common stock upon the exercise of warrants and stock options by unrelated parties which resulted in gross proceeds of approximately $378,000 to the Company.

During the fiscal year ended July 31, 2003, the Company issued an aggregate 186,208 shares of common stock in settlement of accounts payable in the aggregate amount of $94,223.  In addition, one of the vendors was granted five-year options to purchase 50,000 shares of common stock at an exercise price of $1.25 per share.  The Company recorded $17,581 non-cash research and development expenses for these options, based upon the fair value on the date of the issuance as estimated by the Black-Scholes options-pricing model.  The settled accounts payable amount was credited to equity as the value of the common stock and options.

During the fiscal year ended July 31, 2003, the Company issued 25,000 five-year stock options to an unrelated party as an incentive for lending the Company an aggregate of $25,000, which was fully paid as of April 30, 2003.  The stock options vested immediately and have an exercise price of $0.23 per share.  The total non-cash interest expense recorded for these stock options was $2,503.  In addition, the Company issued 140,000 five-year stock options for services rendered.  These stock options vested immediately and have exercise prices of $0.84 and $1.25 per share.  The total non-cash charge relating to these options was $55,437.  The total value of these options was based upon the fair value of such options on the date of issuance as estimated by the Bla ck-Scholes options-pricing model.  Of these options, 20,000 were exercised during the fiscal year ended July 31, 2004.

During the fiscal year ended July 31, 2003, the Company issued 8% convertible notes payable to unrelated parties with principal balances totaling an aggregate of $915,000.  These notes payable were due to mature on various dates from April 2004 through May 2005 and were convertible into the Company’s common stock at conversion prices ranging from $0.20 to $0.50 per share and an equal number of five year warrants with an exercise price of $1.00 per share.  With the issuance of the notes payable, the Company issued to the unrelated parties five year warrants to purchase an aggregate of 665,000 shares of the Company’s common stock, at an exercise price of $0.60 per share.  In addition, the Company issued on the due date of the notes payable five year warrants to purchase an agg regate of 915,000 shares of the Company’s common stock at per share exercise prices of $1.00 and $1.10.  The Company valued these warrants at a total of $219,259 based on the fair value determined by using the Black-Scholes method relative to the fair value of the notes payable.  At the issuance dates of the notes payable, the fair market values of the Company’s shares exceeded the effective conversion prices.  Accordingly, the Company initially increased additional paid-in capital by $219,259 for the relative fair value of the warrants and reduced the carrying value of the notes payable for the same amount for the debt discount attributable to the fair value of the warrants. The Company also increased its additional paid-in capital and debt discount by $374,960 for beneficial conversion rights issued in connection with the issuances of these notes.

During the fiscal year ended July 31, 2003, the Company sold an aggregate of 1,315,000 shares of common stock to private investors at prices ranging from $0.20 to $0.73 per share resulting in net proceeds of $653,627 to the Company.  In addition, the private investors were granted warrants to purchase an aggregate of 1,315,000 shares of common stock at per share exercise prices ranging from $1.00 to $1.50.  The warrants will expire during the period commencing January 2008 and ending in October 2008.  As of July 31, 2008, 965,000 of these warrants were exercised and 150,000 expired.

On January 14, 2004, at the Company’s annual meeting of stockholders, the Company’s stockholders approved an amendment to the Company’s Certificate of Incorporation, as amended, to increase the number of shares of common stock authorized from 40,000,000 to 100,000,000.  Since no notes payable had been converted as of such date, the terms of the Company’s notes payable relating to conversion and exercise which were amended to authorize conversion to Series A Preferred Stock because there were an insufficient number of authorized shares of common stock available for issuance upon conversion, reverted to their original terms so that they were again convertible into shares of common stock, rather than shares of Series A Preferred Stock.

 
F - 35

 
 
On January 14, 2004, at the Company’s annual meeting of stockholders, the Company’s stockholders approved the 2004 Stock Incentive Plan (the “2004 Plan”).  The total number of shares of common stock authorized for issuance under the 2004 Plan is 8,500,000.

During the fiscal year ended July 31, 2004, the Company issued an aggregate of 120,000 shares of common stock to private investors resulting in aggregate gross proceeds of $60,000 to the Company.  In addition, the private investors were granted five-year warrants to purchase 120,000 shares of common stock at an exercise price of $1.25 per share.

During the fiscal year ended July 31, 2004, the Company issued 3,996 five-year stock options to a consultant as payment for services rendered.  The options vested immediately and have a per share exercise price of $0.60.  The Company recorded a total of $5,235 of non-cash expenses for these options, based upon the fair value on the date of the issuance as estimated by the Black-Scholes options pricing model.  These options were exercised during the fiscal year ended July 31, 2004 resulting in gross proceeds of $2,398 to the Company.

During the fiscal year ended July 31, 2004, the Company entered into a two-part financing agreement with SF Capital Partners, Ltd. for the private placement of 1,704,546 shares of common stock and warrants to purchase 852,273 shares of common stock, at an exercise price of $1.50 per share.  As consideration, the Company received $1,500,000.  In addition, the Company granted SF Capital Partners, Ltd. a warrant to invest an additional $1,500,000 to purchase the Company’s common stock at an exercise price based upon a 20-day trailing average of the closing price per share of the Company’s common stock (the “Additional Warrants”).  During the fiscal year ended July 31, 2004, SF Capital Partners, Ltd. exercised the Additional Warrants at a 20-day trailing average exer cise price of $3.96 which resulted in gross proceeds of $1,500,000 and the issuance of 379,170 shares of common stock and an Exercise Warrant to purchase an additional 189,585 shares of common stock at a per share exercise price of $4.75.  The Company also issued an aggregate of 53,876 shares of restricted common stock to a third party as finder’s fee.  During the fiscal year ended July 31, 2006, the exercise price of the Exercise Warrant to purchase an additional 189,585 shares of common stock was reduced from $4.75 to $2.88 per share.  As of July 31, 2007, none of these options were exercised.

During the fiscal year ended July 31, 2004, the Company issued 25,000 five-year stock options to a board member as payment for non-board related services and 110,000 five-year stock options to various consultants for services rendered.  The options vested immediately and have a per share exercise price of $3.46.  The Company recorded a total of $275,377 non-cash expenses for these options, based upon the fair value on the date of the issuance as estimated by the Black-Scholes options pricing model.  As of July 31, 2007, 5,000 of these options were exercised.

During the fiscal year ended July 31, 2004, the Company issued an aggregate of 14,703 restricted shares of common stock as payment of accounts payable in the amount of $52,176.

During the fiscal year ended July 31, 2004, the Company issued an aggregate of 75,000 restricted shares of common stock as payment for services rendered in an aggregate amount of $288,500.

During the fiscal year ended July 31, 2004, the Company issued 1,210,654 shares of common stock to an existing institutional investor, resulting in gross proceeds of $10,000,000 to the Company.  In addition, the institutional investor was granted five-year warrants to purchase 1,210,654 shares of Common Stock at an exercise price of $12.39 per share.  The Company paid a 5% finder’s fee to a third party in connection with the private placement, which included a five-year warrant to purchase 60,533 shares of common stock at an exercise price of $12.39 per share. During the fiscal year ended July 31, 2006, the exercise price of the warrants to purchase an aggregate of 1,185,000 shares of common stock was reduced from $12.39 to $2.88 per share.

During the fiscal year ended July 31, 2004, the Company increased its outstanding shares by 40,000 shares of common stock for replacement of previously issued stock.

During the fiscal year ended July 31, 2004, the Company issued an aggregate of 3,042,817 shares of restricted common stock and five-year warrants to purchase 3,733,839 shares of common stock with exercise prices ranging from $1.00 to $1.10 per share upon the conversion of notes payable and accrued interest in the amount of approximately $927,872.

 
F - 36

 
 
During the fiscal year ended July 31, 2004, the Company issued an aggregate of 2,676,994 shares of common stock upon the exercise of warrants by unrelated parties and stock options by unrelated parties, employees, a director and former director at per share exercise prices ranging from $0.26 to $4.74.  The Company realized aggregate gross proceeds of $2,656,099 from these exercises.

During the fiscal year ended July 31, 2004, the Company incurred an aggregate of $824,022 of costs relating to various private placements.

During the fiscal year ended July 31, 2005, the Company issued an aggregate of 1,744,978 shares of common stock and five-year warrants to purchase an aggregate of 2,044,978 shares of common stock with an exercise price of $1.00 per share upon the conversion of notes payable and its accrued interest in an aggregate amount of $464,499.

During the fiscal year ended July 31, 2005, the Company issued an aggregate of 438,372 shares of common stock upon the exercise of stock options and warrants by unrelated parties, employees and a director at per share exercise prices ranging from $0.26 to $1.91.  The Company realized aggregate net proceeds of $307,155 from these exercises.

During the fiscal year ended July 31, 2005, the Company issued 3,000 shares of restricted common stock as payment for services rendered.  A non-cash expense of $13,500 was recorded by the Company for these shares, based upon the fair value of the common stock at the date of issuance.

During the fiscal year ended July 31, 2005, the Company issued 12,500 warrants to a vendor in consideration for services to be rendered.  5,000 of these warrants which vested immediately have an exercise price of $2.50 per share and 7,500 warrants which vested on the 91st day from the grant date have an exercise price of $3.50 per share.  These warrants will expire 24 months from the date the registration statement registering the shares underlying the warrants is declared effective or 36 months from the date of grant, whichever comes first.  These warrants expired during the fiscal year ended July 31, 2008.  The Company recorded a total of $13,552 of non-cash expense for these warrants, based upon the fair value at July 31, 2005 as estimated by the Black-Scholes option pricing model.

During the fiscal year ended July 31, 2005, the Company issued an aggregate of 20,000 ten-year stock options to consultants as payment for continuing services.  The options will vest 25% each year starting on the first anniversary of the commencement of the services of the consultants provided they remain as consultants on the relevant vesting dates.  The stock options have an exercise price of $2.05 per share.  The Company recorded a total of $3,237 of non-cash expense for these options, based upon the fair value at July 31, 2005 as estimated by the Black-Scholes option pricing model.  During the fiscal year ended July 31, 2006, the Company recorded under EITF 96-18, a total of $15,066 of non-cash expense for these options.
 
During the fiscal year ended July 31, 2006, the Company issued an aggregate of 1,122,827 shares of common stock upon the exercise of warrants and stock options by unrelated parties, consultants, employees, directors and an executive officer at per share exercise prices ranging from $0.26 to $3.46.  The Company realized aggregate gross proceeds of $1,348,324 from these exercises.
 
During the fiscal year ended July 31, 2006, the Company issued 25,000 ten-year stock options to a consultant as payment for services rendered.  The options vested immediately and have an exercise price of $1.32 per share.  The Company recorded a total of $23,166 of non-cash expense for these options.
 
During the fiscal year ended July 31, 2006, the Company issued 25,000 ten-year stock options to a consultant as payment for services rendered.  The options vested immediately and have an exercise price of $3.37 per share.  The Company recorded a total of $58,387 of non-cash expense for these options.

During the fiscal year ended July 31, 2006, the Company issued 50,000 five-year stock options to a consultant as payment for services to be rendered.  These options vest over a one year period, 50% of which vested immediately and 12.5% will vest equally for the next four quarters following the grant date.  The stock options have an exercise price of $2.04 per share and are subject to variable accounting under EITF 96-18.  The fair value of these options is being expensed over the service period.  During the fiscal year ended July 31, 2006, the Company recorded a total of $74,253 of non-cash expense for these options.
 
 
F - 37

 
 
During the fiscal year ended July 31, 2006, the Company issued 174,927 shares of restricted common stock to a private investor resulting in gross proceeds of $600,000 to the Company for a purchase price of $3.43 per share.
 
During the fiscal year ended July 31, 2006, the Company completed a private placement to various institutional investors which resulted in the issuance of an aggregate of 6,457,172 shares of restricted common stock for a purchase price of $1.75 per share.  The institutional investors also received warrants to purchase up to an additional 6,457,172 shares of common stock of the Company.  The fair value of the warrants at the grant date was approximately $12,962,000 as estimated using the Black-Scholes options pricing model.  The warrants have a term of five years and were issued in two separate series.  The first series of warrants (to purchase 3,228,590 shares of common stock) are exercisable beginning on January 19, 2007, and the second series of warrants (to purchase 3,228,5 82 shares of common stock) are also exercisable beginning on January 19, 2007.  Both sets of warrants have an exercise price equal to $2.88 per share.  If the Company enters into a strategic corporate collaboration as outlined in the second series of warrants by December 31, 2006, the second series of warrants will be cancelled upon notification by the Company to the holders of the warrants that it has entered into such an agreement prior to such date.  The Company did not enter in such agreement by the specified time therefore, the second series of warrants were not canceled.  The Company received net proceeds of approximately $10,384,000 from this private placement.  The Company filed a registration statement on Form S-3 to register the resale of the shares and the shares issuable upon exercise of the warrants, which was declared effective in August 2006.  If the Company had failed to file the registration statement, request effectiveness of the r egistration statement, respond to comments of the Securities and Exchange Commission, or cause the registration statement to be declared effective in a timely manner in accordance with the provisions of the registration rights agreement between the Company and the investors, or if the registration statement ceases to remain effective, or the investors are otherwise not permitted to utilize the prospectus in the registration statement to resell the securities for more than 15 consecutive calendar days or more than an aggregate of 25 calendar days during any 12-month period (which need not be consecutive calendar days), then the Company must pay to each investor an amount, in cash, as partial liquidated damages and not as a penalty, equal to 2% of the aggregate purchase price paid by such investor for any securities registered on the registration statement that are then held by such investor monthly until the failure is cured.  However, the Company shall not be required to pay partial liquidated dama ges to the investor in excess of 10% of the purchase price such investor paid for the registered securities.  If the Company fails to pay any partial liquidated damages in full within seven days after the date payable, the Company will pay interest thereon to the investor at a rate of 18% per annum (or such lesser maximum amount that is permitted to be paid by applicable law), accruing daily from the date such partial liquidated damages are due until such amounts, plus all such interest thereon, are paid in full.

During the fiscal year ended July 31, 2007, the Company issued an aggregate of 295,800 shares of its common stock upon the exercise of stock options by an officer, employees and unrelated parties at per share exercise prices ranging from $0.23 to $2.16.  The Company realized aggregate gross proceeds of $352,256 from these exercises.

During the fiscal year ended July 31, 2007, the Company issued an aggregate of 1,142,559 shares of its common stock upon the exercise of warrants by related and unrelated parties at per share exercise prices ranging from $0.60 to $2.88.  The Company realized aggregate gross proceeds of $1,153,444 from these exercises.

During the fiscal year ended July 31, 2007, the Company issued an aggregate of 130,000 ten-year stock options to various consultants for services rendered.  The options vested immediately and have an exercise price of $1.71 per share.  The Company recorded the total fair value of $176,800 of non-cash expense for these options upon issuance.

During the fiscal year ended July 31, 2007, the Company issued 10,000 ten-year stock options to a consultant for serving in the Scientific Advisory Board.  The options vested immediately and have an exercise price of $1.49 per share.  The Company recorded the total fair value of $11,660 of non-cash expense for these options upon issuance.

 
F - 38

 
 
In July 2007, the Company and USP Pharma Spolka Z.O.O. ("USP") entered into a Distribution and Marketing Agreement (the "Agreement").  The Agreement appoints USP as the Company’s exclusive distributor in Poland, Lithuania, Estonia, Latvia, Belarus and the Ukraine in the field of Oncology.  Included in the Agreement is an up-front fee as consideration for the appointment of USP as the Company’s distributor in the defined territory.  Based upon its review of SAB No. 101, “Revenue Recognition in Financial Statements”, and SAB No. 104, “Revenue Recognition”, the Company has determined that the up-front fee is to be recognized on a straight line basis over the term of the Agreement.  The term of the Agreement is defined as the earlier of ten (10) years after the first commercial sale or the expiration of the patents covering the Company’s product in the defined territory.  The Agreement also includes multiple milestone payments and the payment of royalties.  The milestone payments are to be paid to the Company upon the attainment of those milestones as defined in the Agreement.  The royalty payments by USP to the Company are based on a fixed percentage of net sales.  No revenue has been recognized for the up-front fee, milestone achievements and royalties in the accompanying financial statements.  In connection with the Distribution Agreement, the Company and Unilab LP, an affiliate of US Pharmacia, entered into a Securities Purchase Agreement, (the "Purchase Agreement"), pursuant to which the Company issued an aggregate of 553,360 shares of its restricted common stock for purchase price of $2.53 per share.  The Company realized gross proceeds of $1,400,000.  The securities sold pursuant to the Purchase Agreement have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States in the absence of an effective registration statement or exemption from registration requirements.

During the fiscal year ended July 31, 2008, the Company issued an aggregate of 760,000 shares of its common stock upon the exercise of warrants by unrelated parties at per share exercise prices ranging from $0.60 to $1.25.  The Company realized aggregate gross proceeds of $541,500 from these exercises.

During the fiscal year ended July 31, 2008, the Company issued an aggregate of 236,000 shares of its common stock upon the exercise of stock options by an officer and employees at per share exercise prices ranging from $0.26 to $1.58.  The Company realized aggregate gross proceeds of $145,540 from these exercises.

During the fiscal year ended July 31, 2008, the Company issued an aggregate of 265,000 stock options to the independent members of its board of directors with an exercise price of $1.72 per share and a six-year exercise term.  The aggregate grant date fair market value of these options, $275,865, is being amortized over the one-year vesting period.  The Company recognized an aggregate compensation expense of $154,705 and $121,160 for the fiscal years ended July 31, 2008 and 2009, respectively.

During the fiscal year ended July 31, 2008, the Company issued an aggregate of 40,000 stock options to various non-employee consultants for services rendered.  The options vested immediately, have an exercise price of $1.75 per share and a ten-year exercise term.  The aggregate grant date fair market value of these options, $52,840, was recognized as an expense by the Company during the fiscal year ended July 31, 2008.

During the fiscal year ended July 31, 2008, the Company issued an aggregate of 330,000 stock options to various non-employee consultants for serving as the Company’s scientific advisors and research collaborators and for contributions made on behalf of the Company’s pre-clinical and clinical research programs.  Of these options, 110,000 vested immediately, 50% of the balance will vest after one year and the remaining 50% of the balance will vest after two years.  The options have an exercise price of $1.75 per share and a ten-year term.  Under the variable accounting provisions of EITF 96-18, the aggregate grant date fair market value of these options, $456,730, is being amortized over the vesting period and is being re-measured as of each reporting period.  The ag gregate re-measured fair market value of these options was estimated to be $189,872 and $174,153, for the fiscal years ended July 31, 2008 and 2009, respectively.  These options fully vested during the fiscal year ended July 31, 2010 with the aggregate re-measured fair value of $192,296.

During the fiscal year ended July 31, 2008, the Company issued 250,000 stock options to its CEO, Kuslima Shogen, with an exercise price of $2.18 per share and a ten-year exercise term.  The options, which were granted as a bonus for entering into an agreement for the marketing rights to ONCONASE® in the U.S., vested immediately and have a grant date fair market value of $405,000 which was recognized as an expense by the Company during the fiscal year ended July 31, 2008.  These options expired during the fiscal year ended July 31, 2010.

During the fiscal year ended July 31, 2008, the Company entered into a retirement agreement (see Note 12) with Kuslima Shogen, its CEO.  Under the terms of the agreement, the Company issued 1,000,000 stock options with an exercise price of $2.00 per share.  The options have a ten-year contractual term and will become exercisable only upon the approval of an ONCONASE® NDA by the United States Food and Drug Administration (“FDA”) for the treatment of malignant mesothelioma.  The grant date fair market value of these options, $1,900,000, is being amortized over the estimated vesting period.  The Company recognized compensation expense of $429,762, $619,762 and $179,048 for the fiscal y ears ended July 31, 2008, 2009 and 2010, respectively.

During the fiscal year ended July 31, 2009, the Company issued an aggregate of 37,000 shares of its common stock upon the exercise of stock options by various employees at per share exercise prices ranging from $0.26 to $0.54.  The Company realized aggregate gross proceeds of $13,220 from these exercises.
 
 
F - 39

 

During the fiscal year ended July 31, 2009, the Company issued an aggregate of 265,000 stock options to the independent members of its board of directors with an exercise price of $0.24 per share and a six-year exercise term.  The aggregate grant date fair market value of these options in the amount of $42,400 is being amortized over the one-year vesting period.  Of these options, 35,000 shares were forfeited as of July 31, 2009.  The Company recognized an aggregate compensation expense of $21,128 and $37,522 for the fiscal years ended July 31, 2009 and 2010, respectively.

On April 27, 2010, at the Company’s annual stockholders’ meeting, the Company’s stockholders approved an amendment to the Company’s Certificate of Incorporation, as amended, to increase the number of shares of common stock authorized from 100,000,000 to 250,000,000.

During the fiscal year ended July 31, 2010, the Company issued 11,667 stock options to its former member of the board of directors with an exercise price of $0.34 per share and a five-year exercise term.  The grant date fair market value of these options in the amount of $2,812 was recognized as an expense for the fiscal year ended July 31, 2010.

During the fiscal year ended July 31, 2010, the Company issued an aggregate of 430,000 stock options to the independent members of its board of directors with an exercise price of $0.26 per share and a sixty-eight month exercise term.  The aggregate grant date fair market value of these options in the amount of $85,570 is being amortized over the eight-month vesting period.   The Company recognized an aggregate compensation expense of $31,447 for the fiscal year ended July 31, 2010.

(8)
Common Stock Warrants

The following table summarizes the activity of common stock warrants issued in connection with the private placements and conversion of notes payable completed in fiscal years 2009 and 2010:
 
 
Warrants
 
Exercise Price
 
Expiration
Outstanding at July 31, 2008
14,862,534 
 
1.00 - 12.39
 
8/13/08 to 7/17/11
Expired
(6,366,884)
 
1.00 – 12.39
 
8/13/08 to 7/15/09
Outstanding at July 31, 2009
8,495,650 
 
1.00 - 2.88
 
9/14/09 to 7/17/11
Expired
(2,044,978)
 
1.00
 
9/14/09 to 5/6/10
Issued to related parties in connection with conversion of notes payable
13,333,332 
 
0.15 – 0.25
 
10/19/12 to 10/19/14
Issued to unrelated parties in connection with conversion of notes payable
29,999,996 
 
0.15 – 0.25
 
10/19/12 to 10/19/14
Outstanding at July 31, 2010
49,784,000 
 
$0.15 - $2.88
 
7/17/11 to 10/19/14
Exercisable at July 31, 2010
49,784,000 
 
$0.15 - $2.88
 
7/17/11 to 10/19/14

(9)      Stock Options

2004 Stock Incentive Plan

The Company's stockholders approved the 2004 Stock Incentive Plan (the “2004 Plan”) for the issuance of up to 8,500,000 shares, which provides that common stock and stock options may be granted to employees, directors and consultants.  The 2004 Plan provides for the granting of stock options, stock appreciation rights, restricted shares, or other share based awards to eligible employees and directors, as defined in the 2004 Plan.  Options granted under the 2004 Plan will have an exercise price equal to the market value of the Company’s common stock on the date of the grant. The term, vesting period and time and method of exercise of options granted under the 2004 Plan are fixed by the Board of Directors or a committee thereof.

 
F - 40

 
 
1997 Stock Option Plan

The Company’s stockholders approved the 1997 stock option plan for the issuance of options for up to 2,000,000 shares, which provides that options may be granted to employees, directors and consultants.  Options are granted at market value on the date of the grant and generally are exercisable in 20% increments annually over five years starting one year after the date of grant and terminate five years from their initial exercise date.  This plan expired in May 2007 except to the extent there are outstanding options.
 
1993 Stock Option Plan

The Company's stockholders approved the 1993 stock option plan for the issuance of options for up to 3,000,000 shares, which provides that options may be granted to employees, directors and consultants.  Options are granted at market value on the date of the grant and generally are exercisable in 20% increments annually over five years starting one year after the date of grant and terminate five years from their initial exercise date.  This plan expired in November 2003 except to the extent there are outstanding options.

Option Activity

The following table summarizes stock option activity for the period August 1, 2008 to July 31, 2010:

 
Shares
Available for Grant
   
Options
Outstanding
   
Weighted Average Exercise Price Per Share
   
Weighted Average Remaining Contractual Term
   
Aggregate
Intrinsic Value
 
Balance July 31, 2008
3,926,983       6,353,067       2.69              
      Granted
(265,000 )     265,000       0.24              
      Exercised
--       (37,000 )     0.36              
      Cancelled/Expired
1,058,005       (1,512,905 )     2.74              
      Forfeited
292,512       (296,512 )     1.42              
Balance July 31, 2009
5,012,500       4,771,650       2.64              
      Granted
(941,667 )     941,667       0.30              
      Cancelled/Expired
1,096,500       (2,169,850 )     3.56              
      Forfeited
8,000       (8,000 )     1.29              
Balance July 31, 2010
5,175,333       3,535,467     $ 1.45     6.03     $ 25,000  
Exercisable at July 31, 2009
        3,415,650     $ 3.02     2.14     $ 3,030  
Exercisable at July 31, 2010
        1,605,467     $ 1.78     4.13     $ 12,100  

(10)    Income Taxes

The Company accounts for income taxes under the provisions of ASC Accounting for Income Taxes.  Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement carrying amounts and tax bases of assets and liabilities using enacted tax rates in effect for all years in which the temporary differences are expected to reverse.

New Jersey has enacted legislation permitting certain corporations located in New Jersey to sell a portion of its state tax loss carryforwards and state research and development credits in order to obtain state tax benefits.  For the state fiscal year 2010 (July 1, 2009 to June 30, 2010), the Company had approximately $723,000 of total available state tax benefit that was saleable.  In February 2010, the Company received approximately $647,000 from the sale of its total available state tax benefit, which was recognized as state tax benefit in the fiscal year ended July 31, 2010.  For the state fiscal year 2009 (July 1, 2008 to June 30, 2009), the Company had approximately $1,274,000 of total available state tax benefit that was saleable.  On December 1, 2008, the Company recei ved approximately $1,140,000 from the sale of its total available state tax benefit, which was recognized as state tax benefit in the fiscal year ended July 31, 2009.  For the state fiscal year 2011 (July 1, 2010 to June 30, 2011), the Company did not qualify to participate in the program.

 
F - 41

 
 
At July 31, 2010 and 2009, the tax effects of temporary differences that give rise to the deferred tax assets are as follows:

 
Deferred tax assets:
 
2010
   
2009
 
     Excess of book over tax depreciation and amortization
  $ 9,727     $ (2,867 )
     Stock options
    2,724,202       2,628,892  
     Deferred revenue
    2,080,000       2,080,000  
     Temporary differences
    5,475,673       479,020  
     Federal and state net operating loss carryforwards
    23,277,136 *     23,641,138 *
     Research and experimentation credit carryforwards
    2,329,646 *     2,578,601 *
     Total gross deferred tax assets
    35,896,384       31,404,784  
     Valuation allowance
    (35,896,384 )     (31,404,784 )
     Net deferred tax assets
  $     $  

*  Net of amount sold pursuant to New Jersey state tax legislation.

A valuation allowance is provided when it is more likely than not that some portion or all of the deferred tax assets will not be realized.  The tax benefit assumed using the federal statutory tax rate of 34% has been reduced to the actual benefits reflected on the statements of operations due principally to the aforementioned valuation allowance.  In 2010 and 2009 the valuation allowance increased by $4,492,000 and $348,000, respectively.

At July 31, 2010, the Company has federal net operating loss carryforwards of approximately $67,510,000 that expire in the years 2011 to 2030 (approximately $20,431,000 expires in the years 2011 to 2015) and state net operating loss carryforwards of approximately $5,394,000 that expire in years 2018 to 2019.  The Company also has federal research and experimentation tax credit carryforwards of approximately $2,210,000 that expire in the years 2011 to 2030 (approximately $623,000 expires in the years 2011 to 2015) and state research and experimentation tax credits of approximately $119,000 that expire in the years 2024 to 2025.  Ultimate utilization/availability of such net operating losses and credits is dependent upon the Company’ ;s ability to generate taxable income in future periods and may be significantly curtailed if a significant change in ownership occurs in accordance with the provisions of the Tax Reform Act of 1986.

Effective August 1, 2007, the Company adopted ASC Accounting for Uncertainty In Income Taxes which clarifies the accounting and disclosure for uncertainty in income taxes.  The adoption of this interpretation did not have any material impact on the Company’s financial statements, as there were no unrecognized tax benefits as of August 1, 2007 or during the fiscal years ended July 31, 2010 and 2009.

The Company files income tax returns in the U.S. federal jurisdiction and New Jersey.  For federal income tax purposes, fiscal 2007 through 2010 tax years generally remain open for examination by the tax authorities under the normal three-year statute of limitations.  For New Jersey tax purposes, fiscal 2006 through 2010 tax years generally remain open for examination under a four-year statute of limitations.
 
(11)    Related Party Transactions
 
On October 19, 2009, Charles Muniz, the Company’s President, Chief Executive Officer and Chief Financial Officer, was a party to the Securities Purchase Agreement, the Investor Rights Agreement, the Security Agreement and the Escrow Agreement.  The Company’s entry into an employment agreement with Mr. Muniz upon terms reasonably acceptable to the investors in the Offering was a condition to the Closing.

In December 2009, the Company engaged Champions Biotechnology, Inc. to provide certain services for approximately $99,900.  The Company’s non-executive Chairman of the Board of Directors, Dr. David Sidransky, is also the chairman of the board of directors as well as a principal stockholder of Champions Biotechnology, Inc.  As of July 31, 2010, the agreed amount was paid in full.

 
F - 42

 
 
(12)    Commitments

Employment and Retirement Agreements

On April 28, 2008, the Company entered into a retirement agreement (the “Retirement Agreement”) with Ms. Shogen.  Under the terms of the Retirement Agreement, Ms. Shogen was entitled to receive her then current annual salary of $300,000 and participate in all benefit plans available for the Company’s executives through her retirement date, which occurred on March 31, 2009 (the “Termination Date”).  Ms. Shogen will receive retirement payments of $300,000 for each of the two years after the Termination Date.  During the fiscal year ended July 31, 2008, the Company accrued these benefits in the amount of $612,000.

On September 14, 2009, the Company entered into an amendment (the “Amendment”) to the Retirement Agreement amending certain terms.  Pursuant to the Amendment, effective as of September 14, 2009, periodic payments owed to Ms. Shogen under the Retirement Agreement during the two year period commencing April 1, 2008 will be paid at the rate of $150,000 per year, rather than $300,000 per year as originally provided in the Retirement Agreement.  Under the Retirement Agreement, Ms. Shogen was entitled to receive continuing payments equal to 15% of any royalties received by the Company pursuant to any and all license agreements entered into by the Company for the marketing and distribution of Licensed Products. Under the Amendment, the amount of such royalties related to net sales of License d Products to be received by Ms. Shogen has been reduced to 5%.  Under the Retirement Agreement, Ms. Shogen was entitled to receive continuing payments equal to 5% of net sales of Licensed Products booked by the Company on its financial statements.  Under the Amendment the amount of such net sales booked by the Company has been reduced to 2%. Under the Amendment, in the event the Company obtains marketing approval for ONCONASE® from the Food and Drug Administration or the European Medicines Agency, Ms. Shogen will be entitled to receive an additional payment equal to the difference between the periodic payments actually paid to Ms. Shogen during the two year period commencing April 1, 2008 and $600,000, the original amount of periodic payments to which Ms. Shogen was entitled under the Retirement Agreement.  Such additional payment may be made by the Company, at its option, in cash, the Company c ommon stock or a combination of both.  The Amendment is binding on the parties as of September 14, 2009.  Except as specifically amended in the Amendment, all terms and conditions of the Retirement Agreement remain in full force and effect.
 
On October 19, 2009, the Company entered into an Employment Agreement (the “Employment Agreement”) with Mr. Muniz.  Pursuant to the Employment Agreement, Mr. Muniz shall serve as the Company’s President, Chief Executive Officer and Chief Financial Officer. Mr. Muniz will receive an annual base salary of $300,000 and is entitled to receive cash incentive compensation or annual stock option awards as determined by the Board or the Compensation Committee of the Board from time to time. In addition, Mr. Muniz is entitled to participate in any and all employee benefit plans established and maintained by the Company for executive officers of the Company. Pursuant to the Employment Agreement, Mr. Muniz received an option (the “Option”), granted under and in accordance with the Company’s 2004 Stock Incentive Plan, to purchase an aggregate of 500,000 shares of Common Stock exercisable for ten years from the date the Option is granted. The Option shall vest in equal amounts on each of the first, second and third year anniversary of the grant so long as Mr. Muniz remains employed by the Company. The exercise price of the Option was equal to the fair market value of the Common Stock on the date of grant.  The Employment Agreement continues in effect for two years following the date of the agreement and automatically renews for successive one-year periods, unless Mr. Muniz’s employment is terminated by him or by the Company. In the event that Mr. Muniz’s employment is terminated by the Company for any reason, then Mr. Muniz is entitled to receive his earned but unpaid base salary and incentive compensation, unpaid expense reimbursements, accrued but unused vacation and any vested benefits under any employee benefit plan of the Company. In the event that Mr. Muniz’s employment is terminated by the Company without “cause” or by Mr. Muniz for “good reason” (as such terms are defined in the Employment Agreement), then in addition to the above mentioned payments and benefits, Mr. Muniz is entitled to receive an amount equal to his then current annual base salary, payable in equal installments over 12 months in accordance with the Company’s payroll practice and all medical and health benefits for 18 months following the termination date. Mr. Muniz’s Employment Agreement requires him to refrain from competing with the Company and from hiring our employees and soliciting our customers for a period of one year following the termination of his employment with the Company for any reason.
 
Mr. Muniz is an investor in the Company’s Offering and is party to the Securities Purchase Agreement, the Investor Rights Agreement, the Security Agreement and the Escrow Agreement.

 
F - 43

 
Lease Commitment

On March 14, 2007 the Company entered into an operating lease agreement for a period of ten years to lease space to relocate its corporate headquarters and laboratories to a new location in Somerset, New Jersey.  This lease expires on the tenth anniversary plus 150 days after the commencement date of the lease which expiration date is expected to be November 2017.  The first rental payment occurred on July 3, 2007 which is the lease commencement date.  The lease may be renewed at the option of the Company for a period of two additional terms of 60 months each.  In addition, the Company has received an incentive allowance of $205,000 with an option to receive an additional incentive allowance of $105,000.  As of July 31, 2007 the Company has not exercised the addition al incentive allowance of $105,000.  Both allowances must be used for the cost of leasehold improvements made to the premises.  If all or any portion of the remaining allowance is not used by the end of the original lease term  of ten years any remaining balance may not be applied to the balance of any rent due at the conclusion of the initial lease term.  As part of the operating lease agreement signed on March 14, 2007 the Company agreed to enter into an irrevocable letter of credit in the amount of $350,000 as security for such operating lease.  This irrevocable letter of credit is collateralized by $350,000 in cash which is recorded in “Other Assets” in fiscal year ended July 31, 2008.  If no event of default occurs under the operating lease the Company may reduce its security deposit under the operating lease to $250,000 on July 1, 2011, the fourth anniversary of the lease commencement date.  In the event of no default as of July 1, 2012, the fifth anniversary of the lease commencement date, the irrevocable letter of credit may be reduced to $150,000 until the initial term of the lease expires in 2017.  As of July 31, 2010, the irrevocable letter of credit was reduced by $83,720 for payment of rent.  Rent expense charged to operations was approximately $308,000 and $300,000 for fiscal year ended July 31, 2009 and 2008, respectively.

In June 2007, the Company entered into an operating lease agreement for its office equipment for the term of five years with a payment of approximately $1,600 per month.  As part of the lease agreement, the Company agreed to terminate its existing office equipment lease.  As a result of the early termination of the existing lease, the Company recognized an expense of approximately $31,000 which will be amortized using straight-line method over the term of the lease and will be charged as a reduction from the equipment rental expense.  The new lease did not commence until August 2007.  Rent expense charged to operations was approximately $12,000 for fiscal years ended July 31, 2010 and 2009.  Under the previous lease agreement, equipment rental expense charged to oper ations was $12,000 for the fiscal year ended July 31, 2008.

In November 2007, the Company entered into a capital lease agreement for its building security system for the term of five years with a payment of $635 per month.  The lease agreement also gives the Company the right to purchase the leased equipment at the end of the lease term for $1.00 plus applicable taxes.

In January 2010, the Company vacated its old facility pursuant to the complaint filed by its landlord, I&G in November 2009.  In February 2010, I&G withdrew the remaining balance of the Company’s secured irrevocable letter of credit which was placed in March 2007 in the amount of approximately $81,000.  On February 5, 2010, I&G commenced an action against the Company.  The lawsuit seeks unspecified damages for an alleged breach of a lease agreement dated March 14, 2007 between the Company and I&G.  On or before November 1, 2010, the Company and I&G entered into a Settlement Agreement and Mutual Release whereas I&G agreed to receive $200,000 in consideration of the release in full and complete settlement of all claims made by I&G.

On January 15, 2010, Mr. Muniz, as an individual, entered into a quarterly lease agreement with I&G for office space at the fourth floor of 300 Atrium Drive, Somerset, NJ, which space the Company will occupy as its new office.  The lease expired on September 30, 2010, but was renewable for successive three-month periods upon thirty days prior notice and payment of $15,790.50 for the following three months’ rent.  The Company did not renew this lease upon its expiration.
 
On September 28, 2010, the Company entered into an office lease agreement effective as of October 1, 2010 with Princeton Corporate Plaza, LLC for $3,794 per month including expenses.  The Company leased 2,046 square feet of office and laboratory space in the building located at 11 Deer Park Drive, Suite 204, in the township of South Brunswick in the County of Middlesex, State of New Jersey.  The new office replaced 300 Atrium Drive, Somerset, New Jersey 08873 as its principal executive offices. The lease term began on October 1, 2010, ending on September 30, 2011.
 
 
F - 44

 
 
Future minimum lease payments under noncancelable operating leases (with initial or remaining terms in excess of one year) as of July 31, 2010:

       
Payments Due in Fiscal Year
 
 
Total
   
2011
   
2012
   
2013
   
2014 and Thereafter
 
Building lease
$ 245,528     $ 237,940     $ 7,588     $ 0     $ 0  
Equipment lease
  52,588       25,976       25,976       636       -  
Total contractual cash obligations
$ 298,116     $ 263,916     $ 33,564     $ 636     $ 0  

Defined Contribution Retirement Plan (401(k) Plan)

Effective October 1, 1998, the Company adopted a 401(k) Savings Plan (the “Plan”).  Qualified employees may participate by contributing to the Plan subject to certain Internal Revenue Service restrictions.  The Company will match an amount equal to 50% of the first 6% of each participant’s contribution.  The Company’s contribution is subject to a vesting schedule of 0%, 25%, 50%, 75% and 100% for employment of less than one year, one year, two years, three years and four years, respectively, except for existing employees which vesting schedule was based from the date the Plan was adopted.  In April 2009, the Plan was amended to suspend the Company’s matching contribution and no contributions were made during the fiscal year ended July 31, 2010. 60; For the fiscal years ended July 31, 2009, the Company's contributions to the Plan amounted to $17,252.

(13)
Contingencies

The Company has product liability insurance coverage for clinical trials in the U.S. and in other countries where it conducts its clinical trials.  No product liability claims have been filed against the Company.  If a claim arises and the Company is found liable in an amount that significantly exceeds the policy limits, it may have a material adverse effect upon the financial condition and results of operations of the Company.
 
On October 1, 2010, Robert Love, a former Chief Financial Officer and alleged shareholder of the Company, filed an amended complaint in Love v. Tamir Corp. et al., Case No. 3:09-cv-05199-MLC-LHG (the “Amended Complaint”), against the Company and certain of its current and former directors in the United States District Court, District of New Jersey, asserting violations of federal and state securities laws, direct and derivative common law claims for fraud and breach of fiduciary duty, a direct claim for negligent misrepresentation, and derivative claims for gross negligence and corporate waste in connection with the Company’s Phase IIIb clinical trial for ONCONASE®.  The Amended Complaint alleges that the Company misled shareholders by issuing allegedly false projections of when the required number of patients deaths would occur in the Phase IIIb trial.  The Amended Complaint seeks compensatory damages of no less than $350,000, punitive damages of no less than $20 million, and an accounting and constructive trust.  The Company believes that the claims are meritless and intends to defend the case vigorously.
 
Premier Research Group filed and served a lawsuit against the Company in the Superior Court of New Jersey, Law Division, Essex County, on or about July 26, 2009, seeking the recovery of professional fees that arose from clinical trials purportedly performed in Europe by Premier Research Group as assignee of a contract between Tamir Biotechnology, Inc. and IMFORM GmbH dated October 27, 2005.  An Answer with Separate Defenses and Counterclaim was filed on or about July 30, 2009.  In August 2010, both parties entered into a Stipulation of Settlement Agreement (“Stipulation”) whereby the Company will make a payment to Premier in the amount of $100,000 which will be accepted as a payment in full if paid in accordance with the terms of the Stipulation.  The settlement will be paid every 60 days in four equal installments commencing on or before August 6, 2010, ending on or before February 7, 2011.

I & G Garden State, LLC (“I&G”) filed and served a complaint against the Company in the Superior Court of New Jersey Law Division, Special Civil Part Landlord-Tenant Section, Somerset County, on or about October 30, 2009, for non-payment of rent and failure to maintain security deposit.  The complaint seeks to have the Company vacate the property.  On November 13, 2009, the Company and I&G mutually agreed that the Company will vacate the property on or before December 31, 2009.  In January 2010, the Company vacated the facility as per mutual agreement.  In February 2010, I&G withdrew the remaining balance of the Company’s secured irrevocable letter of credit which was placed in March 2007 in the amount of approximately $81,000.  On F ebruary 5, 2010, I&G commenced an action against the Company.  The lawsuit seeks unspecified damages for an alleged breach of a lease agreement dated March 14, 2007 between the Company and I&G.  On or before November 1, 2010, the Company and I&G entered into a Settlement Agreement and Mutual Release whereas I&G agreed to receive $200,000 in consideration of the release in full and complete settlement of all claims made by I&G.
 
 
F - 45

 
 
(14)
Subsequent Events
 
In October 2010, the Company issued 10,000 shares of its common stock upon the exercise of stock options by an employee at per a share exercise price of $0.26.  The Company realized gross proceeds of $2,600 from this exercise.
 
 
 
F - 46
EX-10.56 2 ex10-56.htm EXHIBIT 10.56 ex10-56.htm
Exhibit 10.56
 
TAMIR BIOTECHNOLOGY, INC.

SECOND AMENDMENT
TO INVESTOR RIGHTS AGREEMENT

July 31, 2010
 
This Second Amendment (this “Amendment”) to that certain Investor Rights Agreement dated as of October 19, 2009, as amended on February 26, 2010 (the “Agreement”), by and among Tamir Biotechnology, a Delaware corporation (f/k/a/ Alfacell Corporation) (the “Company”), and the Purchasers is made as of July 31,, 2010.  Capitalized terms used but not defined herein shall have the meanings ascribed to them in the Agreement.
 
RECITALS

Whereas, the Company and the Purchasers wish to amend the Agreement to extend the Filing Deadline and Effectiveness Deadline.

Whereas, pursuant to Section 6(f) of the Agreement, amendment and waiver of provisions of the Agreement require the written consent of the Company and the Holders holding no less than a majority of the Registrable Securities outstanding and issuable (the “Requisite Parties”).

Whereas, the undersigned constitute the Requisite Parties for purposes of effecting this Amendment.

AGREEMENT

Now, Therefore, in consideration of the foregoing, and the representations, warranties, covenants and conditions set forth below, the Company and the Purchasers, intending to be legally bound, hereby agree as follows:

I.
AMENDMENTS TO THE AGREEMENT.
 
 
 

 
 
A.           The definition of “Effectiveness Deadline” in Section 1 of the Agreement is hereby amended to read in its entirety as follows:

“Effectiveness Deadline” means, with respect to the Initial Registration Statement or the New Registration Statement, the ninetieth (90th) calendar day following the Filing Deadline (or, in the event the Commission reviews and has written comments to the Initial Registration Statement or the New Registration Statement, the one hundred twentieth (120th) calendar day following Filing Deadline); provided, however, that if the Company is notified by the Commission that the Initial Registration Statement or the New Registration Statement wil l not be reviewed or is no longer subject to further review and comments, the Effectiveness Deadline as to such Registration Statement shall be the fifth (5th) Trading Day following the date on which the Company is so notified if such date precedes the dates otherwise required above; provided, further, that if the Effectiveness Deadline falls on a Saturday, Sunday or other day that the Commission is closed for business, the Effectiveness Deadline shall be extended to the next Business Day on which the Commission is open for business.  With respect to any Remainder Registration Statement, the Effectiveness Deadline shall be the 90th calendar day following the date that the Company is eligible to file such Remainder Registration Statement pursuant to SEC Guidance (or, in the event the Commission reviews and has written comments to the Remainder Registration Statement , the 120th calendar day following the date that the Company is eligible to file such Remainder Registration Statement pursuant to SEC Guidance); provided, however, that if the Company is notified by the Commission that the Remainder Registration Statement will not be reviewed or is no longer subject to further review and comments, the Effectiveness Deadline as to such Remainder Registration Statement shall be the fifth (5th) Trading Day following the date on which the Company is so notified if such date precedes the dates otherwise required above; provided, further, that if the Effectiveness Deadline falls on a Saturday, Sunday or other day that the Commission is closed for business, the Effectiveness Deadline shall be extended to the next Business Day on which the Commission is open for business.”

B.           The definition of “Filing Deadline” in Section 1 of the Agreement is hereby amended to read in its entirety as follows:

“Filing Deadline” means, with respect to the Initial Registration Statement required to be filed pursuant to Section 2(a), ninety (90) days following the receipt by the Company of a written notice executed by the holders of at least a majority of the then outstanding Registrable Securities requesting that all of their shares be registered, which request may only be made following the consummation by the Company, subsequent to the date of this Amendment, of an equity or debt financing, or license or other similar partnering transaction, in any such case, which results in aggregate gross proceeds to the Company of at least $3,250,000 (a “Demand Request”).  With respect to any Remainder Registration Statement, the Filing Deadline shall be the 30th calendar day following the date that the Company is eligible to file such Remainder Registration Statement pursuant to SEC Guidance, provided, however, that if the Filing Deadline falls on a Saturday, Sunday or other day that the Commission is closed for business, the Filing Deadline shall be extended to the next business day on which the Commission is open for business.”

 
 

 
 
C.           The first sentence of Section 2(a) of the Agreement is hereby amended to read in its entirety as follows:

(a)           On or prior to the Filing Deadline, the Company shall prepare and file with the Commission a Registration Statement covering the resale of all of the Registrable Securities not already covered by an existing and effective Registration Statement for an offering to be made on a continuous basis pursuant to Rule 415 or, if Rule 415 is not available for offers and sales of the Registrable Securities, by such other means of distribution of Registrable Securities as the Holders may reasonably specify (the “Initial Registration Statement”); provided, however, the registration statement filed by the Company on April 30, 2010 (the “4/30/10 Registration Statement”) shall not be considered the Initial Registration Statement or a Registration Statement for purposes of this Agreement.  In the event the Company believes that amending the 4/30/10 Registration Statement and responding to outstanding SEC comments will result in the effectiveness of a registration statement covering the shares of Registrable Securities requested to be registered by the Demand Request faster than preparing and filing a new Initial Registration Statement cover such shares, then the Holders hereby agree that the Company may proceed with such course of action and such amended 4/30/10 Registration Statement, once filed, shall constitute an Initial Registration Statement and Registration Statement hereunder.”

II.
WAIVER.
 
The undersigned Purchasers, on behalf of all Purchasers, hereby waive any and all defaults by the Company under the Agreement and any rights the Purchasers may have to receive Liquidated Damages, in either case, with respect to all matters occurring at or prior to the date of this Amendment.
 
III.
GENERAL.
 
A.           Except as effected by this Amendment, the terms and provisions of the Agreement shall remain unchanged and in full force and effect.
 
B.           This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
 
C.           This Amendment shall be governed by and construed under the laws of the State of New York as applied to agreements among New York residents, made and to be performed entirely within the State of New York, without giving effect to conflicts of laws principles.
 
D.           The titles and subtitles used in this Amendment are used for convenience only and are not to be considered in construing or interpreting this Amendment.
 

[SIGNATURE PAGES FOLLOW]

 
 

 

The parties have executed this Second Amendment as of the date first written above.
 
TAMIR BIOTECHNOLOGY, INC.
By:      /s/ Charles Muniz
Name: Charles Muniz
Title: President, Chief Executive Officer and Chief Financial Officer

 

 
 
 

 

The parties have executed this Amendment as of the date first written above


PURCHASERS:
 
   
/s/ Charles Muniz
/s/ Colleen A. Lowe
Charles Muniz
Colleen A. Lowe
   
   
EUROPA INTERNATIONAL, INC.
/s/ Corinne M. Poquette
 
Corinne M. Poquette
By:      /s/ Fred Knoll
Name: Fred Knoll
Title: Knoll Capital Management, Investment
Manager for Europa International, Inc.
 
 
/s/ David J. McCash
David J. McCash
   
   
   
UNILAB LP
 
   
By:      ____________________________
Name: F. Patrick Ostronic
Title: Director, Unilab GP Inc., General
Partner for Unilab LP
 
   
   
   
MARY M. MCCASH TRUST
DECLARATION DECLARED OCTOBER 20, 2008
 
   
By:      /s/ Mary M. McCash
Name: Mary M. McCash
Title: Trustee
 
   
   
   
THE MICHAEL J. MCCASH LIVING TRUST
 
   
By:       /s/  Michael J. McCas
Name: Michael J. McCash
Title: Trustee and Grantor
 
 
EX-10.57 3 ex10-57.htm EXHIBIT 10.57 ex10-57.htm
Exhibit 10.57

THIS LEASE AGREEMENT, made this 8th day of September, 2010,

Between              Princeton Corporate Plaza, LLC,
a New Jersey limited liability company, located at 7 Deer Park Drive, Suite A, in the Township of South Brunswick in the County of Middlesex and State of New Jersey and having a postal address at Monmouth Junction, NJ 08852( “Landlord”),

And                      Tamir Biotechnology, Inc.,
a New Jersey Corporation, located at 300 Atrium Drive, in the township of Somerset in the County of Middlesex and State of New Jersey and having a postal code of 08873 ( “Tenant”);

Witnesseth that Landlord does hereby lease to Tenant and Tenant does hereby rent from Landlord, the following described premises: approximately 2,046 square feet of space in Landlord’s building at 11 Deer Park Drive, Suite 204 (the “Demised Premises”), in the Township of South Brunswick in the County of Middlesex and State of New Jersey being known as Block 97 Lot 13.05 on the tax map of the Township of South Brunswick (the “Property”) and being further described as the cross-hatched area on the Demised Premises Plan marked Exhibit A attached hereto and made a part h ereof, for a Term of one (1) year, commencing on October 1, 2010 (the “Commencement Date”) and ending on September 30, 2011 (the “Expiration Date”), to be used and occupied only and for no other purpose than office and laboratories (the “Use”), provided, however, that said Use shall be strictly limited and subject to the activities set forth in Tenant’s Application for Nonresidential Use Performance Standards and Tenancy Review submitted to and approved by the Township of South Brunswick regardless of whether said approval has been received as of the date of execution of this Lease (the “Tenancy Review”).

Upon the following Conditions and Covenants:
 
1st
Payment of Rent.  Commencing on the Commencement Date, Tenant covenants and agrees to pay to Landlord, as Base Rent for and during the Term hereof without defense, demand or offset, the sum of Fifteen Thousand Eight Hundred Fifty Two and no/100 Dollars ($15,852.00) payable on the first day of each month during the Term in the following manner:  $1,321.00 per month together with such Additional Rent as may hereinafter be provided (collectively, the “Rent”).  If the Commencement Date shall fall on a day other than the first day of a month, the Base Rent and any Additional Rent payable hereunder shall be apportioned for the number of days remaining in that month from the Commencement Date through the last day of the calendar month in which the Commencement Date occurs.

2nd
Advance Rental.  Upon the execution hereof, Tenant shall pay $15,176.00 to Landlord representing:

 
1)   one month’s advance rental (applied to the first month’s rent) broken out as follows:
 
 
 one (1) month’s Base Rent in the amount of $1,321.00
 one-twelfth (1/12) of Tenant’s Proportionate Share of estimated annual Operating Expenses $1,165.00
 one (1) month's HVAC maintenance in the amount of $70.00
 one (1) month's gas and electric usage in the amount of $1,238.00
 
 
2)   the security required hereunder in the amount of $11,382.00
 
3rd
Not Used.
 
4th
Security.  Tenant has this day deposited with Landlord the sum of $11,382.00, as security for the pay­ment of the Rent hereunder and the full and faithful performance by Tenant of the covenants and conditions on the part of Tenant to be performed.  Said sum shall be returned to Tenant, without interest, after the expiration of the Term hereof provided that Tenant has fully and faithfully performed all such covenants and conditions on the part of Tenant to be performed.  During the Term hereof, Landlord may, if Landlord so elects, have recourse to such security, to make good any default by Tenant in which event Tenant, shall, on demand, promptly restore said security to its original amount.  Liability to repay said security to Tenant shall run with the reversion and title to the Demised Premises, whether any change i n ownership thereof be by voluntary alienation or as the result of judicial sale, foreclosure or other proceedings, or the exercise of a right of taking or entry by any mortgagee.  Landlord shall have the right to assign or transfer said security for the benefit of Tenant, to any subsequent owner or holder of the reversion or title to the Demised Premises, in which case the assignee shall become liable for the repayment thereof as herein provided, and the assignor shall be deemed to be released by Tenant from all liability to return such security.  This provision shall be applicable to every alienation or change in title and shall in no way be deemed to permit Landlord to retain the security after termination of Landlord’s ownership of the reversion or title.  Tenant shall not mortgage, encumber or assign said security without the prior written consent of Landlord.

5th
Net Lease.  It is the purpose and intent of Landlord and Tenant that the Base Rent shall be net to Landlord, so that this Lease shall yield, net to Landlord, the Base Rent specified in the 1st Section of this Lease in each year during the Term of this Lease.  All costs, expenses, taxes, damages and charges of every kind and nature relating to the Demised Premises (except any payment on account of interest and principal under any mortgages or deeds of trust) which may arise or become due during the Term of this Lease shall be paid by Tenant.
 
 
1

 
 
6th
Proportionate Share.
 
1)
The approximate rentable area of the Demised Premises leased to Tenant is approximately 2,046 square feet.  The total rentable area of the building of which the Demised Premises are a part is approximately 57,099 square feet. Tenant's share of costs and charges, if applicable, as set forth in this Lease shall be determined by dividing the rentable square footage of the Demised Premises by the total rentable square footage of the building of which the Demised Premises is a part (“Tenant’s Proportionate Share”).  As of the Commencement Date it is, therefore, established that Tenant's Proportionate Share is three and fifty eight one-hundredths percent (3.58%).

 
2)
Tenant’s Proportionate Share shall be adjusted from time to time as appropriate based upon adjustments to the total square footage of the building and/or the square footage rented by Tenant.

7th           Operating Expenses.
 
1)
It is understood and agreed that in addition to the Base Rent to be paid by Tenant during the Term of this Lease and any renewals thereof, Tenant shall pay to Landlord Tenant’s Proportionate Share of all taxes, assessments, water rents, rates and charges, sewer rents and other governmental impositions. Tenant shall also pay Tenant’s Proportionate Share of Landlord’s cost of the operation of common area appurtenances, the maintenance, repairs and replacements of and for the building of which the Demised Premises are a part, the maintenance, repair and replacement of the parking lot, sidewalks, curbs and landscaped areas, which shall include but not necessarily be limited to the following: cleaning, sweeping, snow removal, striping, landscaping, insurance, lighting, trash removal, and policing if  necessary, plus an administrative charge of fifteen percent (15%) of said costs (“Operating Expenses”).

 
2)
Nothing herein contained shall require or be construed to require Tenant to pay any inheritance, estate, succession, transfer, gift, franchise, corporation, income or profit tax, or capital levy that is or may be imposed upon or that is or may be payable by Landlord, its successors or assigns.

 
3)
Commencing on the Commencement Date, Tenant shall pay monthly Tenant’s Proportionate Share of Operating Expenses based upon Landlord’s reasonable estimate of the current year expenses due from Tenant. Thereafter, Landlord shall provide an actual statement of expenses to Tenant on a calendar year basis and Tenant shall pay or receive a credit for the difference between the actual amount and the estimate.  Tenant's subsequent monthly estimated payments shall be adjusted accordingly.   Upon Tenant's request, Landlord shall provide to Tenant copies of invoices substantiating the statement of actual expenses.  To the extent that Landlord incurs expenses that are disproportionately allocable to Tenant as a result of Tenant's occupancy as  determined by Landlord, Tenant's Proportionate Share shall not apply to said disproportionate expense items and Tenant shall pay the amount that is actually incurred by Landlord as a result of its tenancy.

 
4)
Landlord’s cost for regular HVAC maintenance to units servicing the Demised Premises shall be billed monthly to Tenant as a separate item.

 
5)
Should Tenant's maintenance or service requirements exceed the standard supplied to the other tenants of the Property, Tenant shall pay the additional costs attributable to such extra requirements.  Said additional costs will be billed to Tenant either (i) as incurred or (ii) with the annual Operating Expense reconciliation, in the sole discretion of Landlord.

 
6)
All taxes, charges, costs and expenses which Tenant assumes or agrees to pay under any provisions of this Lease together with all interest and penalties that may accrue thereon in the event of Tenant's failure to pay the same as herein provided shall be deemed to be Additional Rent and, in the event of non-payment, Landlord shall have all the rights and remedies herein provided in the case of non-payment of Rent.

8th
Taxes, Licenses and Fees.  Tenant shall make timely payment of all ad valorem or other taxes and assessments levied upon Tenant’s stock of merchandise, fixtures, furnishings, furniture, equipment, supplies and other property located on or used in connection with the Demised Premises and of all privilege and business licenses, fees, taxes and similar charges.

9th           Tenant's Electric Responsibility.
 
1)
All electrical current utilized by Tenant within the Demised Premises, including, without limitation, HVAC shall be at Tenant's sole cost and expense.  Landlord shall not be liable for any inconvenience or harm caused by any stoppage or reduction of any utilities and services, and in no event shall the stoppage of any utilities and services excuse Tenant from the timely payment of Rent.

 
2)
Landlord may install a separate meter to measure Tenant’s use of electricity and, in such event, Tenant shall, at Tenant’s sole cost and expense, arrange and pay for all utilities and services required for the Demised Premises, including payment of any deposit which may be required by the utility company.

 
3)
In the event a separate meter is not provided, then bills shall be rendered to Tenant based upon an estimated amount of $990.00 per month.  The estimated amount may be adjusted from time to time based upon changes in utility company rates or if, in the judgment of Landlord, Tenant's demand and consumption varies from this estimate.  The amount thereof shall be deemed to be Additional Rent and shall be due and payable at the same time as the monthly installments of Rent shall be due from Tenant.
 
 
2

 

10th         Tenant's Gas Usage Responsibility.
 
1)
Landlord shall provide Tenant heat at Tenant's sole cost and expense.  All gas usage utilized by Tenant within the Demised Premises shall be strictly at Tenant's sole cost and expense.  Landlord shall not be liable for any inconvenience or harm caused by any stoppage or reduction of any utilities and services, and in no event shall the stoppage of any utilities and services excuse Tenant from the timely payment of Rent.

 
2)
Landlord may install a separate meter to measure Tenant's gas usage and, in such event, Tenant shall, at Tenant’s sole cost and expense, arrange and pay for all utilities and services required for the Demised Premises, including payment of any deposit which may be required by the utility company.

 
3)
In the event a separate meter is not provided, then bills shall be rendered to Tenant based upon an estimated amount of $248.00 per month.  The estimated amount may be adjusted from time to time based upon changes in utility company rates or if, in the judgment of Landlord, Tenant's demand and consumption varies from this estimate.  The amount thereof shall be deemed to be Additional Rent and shall be due and payable at the same time as the monthly installments of Rent shall be due from Tenant

11th         Acceptance and Workletter.
 
1)
Landlord shall complete at its own expense and in a good and workmanlike manner all of the alterations set forth on Exhibit B (“Landlord’s Work”) attached hereto and made a part hereof.

 
2)
Tenant acknowledges that it has inspected and examined the Demised Premises and, except as set forth in Exhibit B, has entered into this Lease without any representations on the part of Landlord, its agents or representatives as to the condition thereof, and, except as set forth in Exhibit B,  is leasing and accepting the Demised Premises “as-is” and “where-is”.  No representations or promises, except as specified herein, have been made by or on behalf of Landlord, its agents, employees or representatives, or by any real estate broker, prior to or at the execution of this Lease, and Landlord is not bound by, and Tenant will make no claim on account of, any representation, promise or assurance, expressed or implied, with respect to conditions, repairs, improvemen ts, services, accommodations, concessions or any other matter, other than as contained herein.

12th         Commencement Date.
 
1)
The Commencement Date shall be earlier or later than the date set forth at the beginning of this Lease under the following circumstances:

 
a)    The Lease will not commence until the work listed in Exhibit B, to be performed by Landlord, is substantially completed, unless Tenant chooses to occupy the Demised Premises, or any part thereof, prior to substantial completion, in which case the Commencement Date shall be the date of said occupancy by Tenant and the Expiration Date shall be the last day of the month immediately preceding the 1st anniversary of the Commencement Date.

 
b)    Except as provided in the preceding paragraph, the Commencement Date will not be altered if the work listed in Exhibit B, to be performed by Landlord, is not substantially completed due to (i)changes requested by Tenant to Exhibit B after this Lease was executed or (ii) the failure of Tenant to promptly provide Landlord with any information necessary for the timely completion of the work listed in Exhibit B or (iii) the failure of Tenant to cooperate with Landlord in completion of the work listed in Exhibit B to such an extent as to cause the delay.

 
2)    If the Commencement Date occurs other than on the first day of a month, the Expiration Date shall be the last day of the calendar month in which the 1st anniversary of the Commencement Date occurs. Substantial completion shall be deemed to have occurred even though (i) minor details of Landlord’s work remain to be done, provided such details do not materially interfere with the Tenant’s occupancy of the Demised Premises, or (ii) any work or installation other than Landlord’s work being performed by Tenant itself has not been completed.

 
3)
Landlord shall not be liable for failure to give possession of the Demised Premises, or any part thereof,  upon the Commencement Date by reason of the fact that the Demised Premises, or any part thereof, are not ready for occupancy, or due to a prior tenant holding over in the Demised Premises or due to any other person being in possession of the Demised Premises or for any other reason.

13th
Repairs and Care.  Tenant has examined the Demised Premises and has entered into this Lease without any representation on the part of Landlord as to the condition thereof.  Tenant shall take good care of the Demised Premises and shall at Tenant’s sole cost and expense, make all repairs, including painting and decorating, and shall maintain the Demised Premises in good condition and state of repair.  Tenant shall neither encumber nor obstruct the sidewalks, driveways, yards, entrances, hallways and stairs in and about the Property, but shall keep and maintain the same in a neat and clean condition as to its own activities, free from debris, trash and refuse.
 
14th
Glass,  Damage and Repairs.  In case of the destruction of or any damage to the glass in the Demised Premises, or the destruction of or damage of any kind whatsoever to the Property, which is caused by the carelessness, negligence or improper conduct on the part of Tenant or Tenant’s agents, employees, guests licensees, invitees, subtenants, assignees or successors, Tenant shall promptly repair at its sole cost and expense said damage or replace or restore said glass at Tenant’s sole cost and expense.
 
 
3

 
 
15th
Utilities.  Tenant shall be responsible for the cost of the prompt repair of any utility, ventilating, heating, air conditioning, electrical, gas and other utility lines within the Demised Premises, except if damage outside the Demised Premises is caused by the acts or omissions of Tenant, its agents, servants or employees, in which event Tenant shall likewise be responsible for the cost of repair of such damage outside the Demised Premises. Landlord will guarantee the HVAC and electrical systems for the period of one (1) year from the Commencement Date except in the case where damage is due to the acts or omissions of Tenant, including, but not limited to, Tenant’s failure to reimburse Landlord its HVAC maintenance charges.  Landlord shall not be liable for any inconvenience or harm caused by any stoppage or reduction of any utilitie s and services, and in no event shall the stoppage or reduction of any utilities and services excuse Tenant from the timely payment of Rent.

16th         Alterations and Improvements.
 
1)
No alterations, additions or improvements shall be made, and no climate regulating, air conditioning, cooling, heating or sprinkler systems, television or radio antennas, heavy equipment, apparatus or fixtures, shall be installed in or attached to the Demised Premises, without the prior written consent of Landlord, which shall not be unreasonably withheld, and the issuance of all required permits from all government agencies having jurisdiction.  Except as provided below, all such alterations, additions or improvements installed in or attached to the Demised Premises shall belong to and become the property of Landlord and be surrendered with the Demised Premises and as a part thereof upon the expiration or sooner termination of this Lease, without hindrance, molestation or injury.

 
2)
Provided that Tenant is not in default of any of the terms of this Lease, Tenant shall have the right to remove any trade fixtures which were installed at Tenant’s sole cost and expense; provided, however, that (i) Tenant shall not remove any equipment, furnishings or mechanical fixtures that are fixed in place and mechanically or electrically connected to the building and/or its systems and (ii)Tenant shall restore the Demised Premises to the condition existing prior to the installation of the trade fixtures which are removed, reasonable wear and tear excepted.

17th
Construction Lien.  If any construction, mechanics’ or other liens shall be created or filed against the Demised Premises by reason of labor per­formed or materials furnished for Tenant in the creation, construction, completion, alteration, repair or addition to any building or improvement, Tenant shall, at Tenant’s sole cost and expense within ten (10) days of filing, cause such lien or liens to be satisfied and discharged of record together with any other liens that may have been filed.  Failure to discharge said liens within the aforesaid ten (10) day period shall entitle Landlord to resort to such remedies as are provided herein in the case of any default of this Lease, in addition to any remedies permitted by law.

18th
Tenant Loans and Landlord Subordination.  Should Tenant desire to use its property located within the Demised Premises as collateral on any loan, Landlord shall not be required to execute any documents evidencing its consent and subordination to any such loan unless and until Landlord has been provided with true copies of all of the loan documents, including, but not limited to, the note, the security agreement and a complete description of the proposed collateral.  Any such consent and subordination documents shall be in a form and under terms and conditions that are acceptable to Landlord.

19th
Signs.  Tenant shall not place any signs of any kind whatsoever upon, in or about the Property or any part thereof, except of a design and structure and in or at such places as may be indicated and consented to by Landlord in writing.  In case Landlord or Landlord’s agents, employees or representatives shall deem it necessary to remove any such signs in order to paint or make any repairs, alterations or improvements in or upon the Property or any part thereof, they may be so removed, but shall be replaced at Landlord’s expense when the said repairs, alterations or improvements shall have been completed.  Any signs permitted by Landlord shall at all times conform with all municipal ordinances or other laws and regulations applicable thereto.  Landlord’s consent shall not be required for signs placed within the Demised Premises which are not visible from outside the Demised Premises.

20th
End of Term.  Upon the Expiration Date or sooner termination of this Lease, Tenant shall:  (a) leave the Demised Premises in a “broom clean” condition;  (b) remove all of Tenant’s property;  (c) remove all signs in and about the Demised Premises and restore that portion of the Demised Premises on which they were placed;  (d) repair all damage caused by moving; and (e) return the Demised Premises to Landlord in the same condition as it was at the beginning of the Term, except for normal wear and tear.

21st
Removal of Tenant’s Property.  Any equipment, fixtures, goods or other property of Tenant not removed by Tenant upon the expiration or sooner termi­nation of this Lease or upon any quitting, vacating or abandonment of the Demised Premises by Tenant, or upon Tenant’s eviction, shall be considered as abandoned and Landlord shall have the right, without any notice to Tenant, to sell or otherwise dispose of the same, at the sole cost and expense of Tenant, and shall not be accountable to Tenant for any part of the proceeds of such sale, if any.

22nd
Compliance with Laws, Etc.  Tenant shall promptly comply with (i) all laws, ordinances, rules, regulations, requirements and directives of the Federal, State and Municipal governments or public authorities and of all of their departments, bureaus and subdivisions, applicable to and affecting the Demised Premises, its use and occupancy, for the correction, prevention and abatement of nuisances, violations or other grievances in, upon or connected with the Demised Premises, during the Term; and (ii) all orders, regulations, requirements and directives of the Board of Fire Underwriters or similar authority; and (iii) the requirements of any insurance companies which have issued or are about to issue policies of insurance covering the Property and/or its contents, for the prevention of fire or other casualty, damage or injury, at Tenant’s sole cost and expense.
 
 
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23rd         Environmental Matters.
 
1)
Tenant warrants and represents that, with respect to maintenance and operations thereon of the Demised Premises and any other premises that it occupies anywhere in the United States, it is in compliance with all laws, ordinances, rules, regulations and policies of any government authority having jurisdiction regarding the environment, human health or safety (collectively, “Environmental Laws”), including, but not limited to, its storage and use of chemicals, its generation and disposal of hazardous wastes and the training, education and safety of its employees.

 
2)
Tenant shall remain in compliance with the above representations during its entire occupancy of the Property or any part thereof.

 
3)
Landlord and Landlord’s agents, employees or other representatives shall have the right to demand documentation supporting these representations.  The failure of Tenant to supply any documentation so demanded within thirty (30) days of written notice of such demand (or immediately in the case of an emergency or suspected violation) shall entitle Landlord to the option of canceling this Lease, and the Term hereof is hereby expressly limited accordingly.

 
4)
Tenant shall comply with all of the terms of Exhibit C which is attached hereto and made a part hereof.
 
24th
Restriction of Use.
 
1)
Tenant shall not occupy or use the Demised Premises or any part thereof, nor permit or suffer the same to be occupied or used for any purposes other than for the Use, nor for any purpose deemed unlawful, disreputable, or extra-hazardous on account of fire or other casualty, nor in a manner which interferes with other tenants in the beneficial use of their premises.

 
2)
Tenant covenants and agrees not to suffer, allow or permit any offensive or obnoxious vibration, noise, odor or other undesirable effect to emanate from the Demised Premises or from any machine, equipment or other installation therein, or otherwise suffer, allow or permit the same to constitute a nuisance or otherwise interfere with the safety, comfort or convenience of  Landlord or any of the other tenants or occupants of the building or their customers, clients, patron, guests, agents or invitees, or any others lawfully in or upon the Property.  Tenant, and its employees, customers, clients, patrons, guests, agents or invitees, shall not make or commit any unreasonable noises or disturbances of any kind in the Demised Premises, nor anywhere else on the Property, nor mark or defile the water closets, toilet rooms or the walls, windows, doors or any other part of the Property, nor interfere in any way with other tenants or those having business in the Property.  Tenant, and its employees, customers, clients, patrons, guests, agents or invitees, shall comply with the State of New Jersey’s law regarding smoking in pubic places and will only smoke in designated areas.

 
3)
Tenant shall not conduct, nor permit any other person to conduct, any auction upon the Demised Premises. Tenant shall not permit the Demised Premises to be used for gambling or any other illegal activity. Canvassing, soliciting and peddling on the Property are prohibited, and Tenant shall cooperate to prevent the same.
 
25th         Assignment and Sublet.
 
1)
Tenant shall not, without the prior written consent of Landlord, assign, mortgage or hypothecate this Lease, nor sublet or sublease the Demised Premises or any part thereof or permit any other person or business to use the Demised Premises except as permitted in this 25th Section .  If Tenant shall be a corporation, limited liability company or partnership, a transfer of any interest of any shareholder, member or partner, as the case may be, shall be deemed an assignment of this Lease and subject to the provisions of this Section.  The provisions of this Section shall be binding upon the legal representatives of Tenant and every person to whom Tenant’s interest under this Lease passes by operation of law or otherwise.
 
 
2)
Provided Tenant is not in default under any of the terms or conditions of this Lease, Landlord will not unreasonably withhold consent to a partial sublet of the Demised Premises, provided that Tenant remains in occupancy of the Demised Premises and that the subtenant does not violate any of the terms of this Lease.

 
3)
If Tenant requests Landlord’s consent to an assignment of this Lease or a subletting of all or any part of the Demised Premises, Tenant shall submit to Landlord:  (i) the name of the proposed assignee or subtenant; (ii) the terms of the proposed assignment or subletting; (iii) the nature of the proposed assignee or subtenant’s business and its proposed use of the Demised Premises; (iv) such information as to the financial responsibility and general reputation of the proposed assignee or subtenant as Landlord may require; and (v) a summary of plans and specifications for revising the floor layout of the Demised Premises.
 
 
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4)
Upon receipt of all such information from Tenant, Landlord shall have the option, to be exercised in writing within thirty (30) days after such receipt, to cancel and terminate this Lease if the request is to assign this Lease or to sublet all or substantially all of the Demised Premises or, if the request is to sublet a portion of the Demised Premises only, to cancel and terminate this Lease with respect to such portion, in each case as of the date set forth in Landlord’s notice of exercise of such option which shall not be less than thirty (30) nor more than ninety (90) days after the date of such notice.  If Landlord shall fail to exercise its option to cancel and terminate this Lease with respect to all or a part of the Demised Premises as above provided, Landlord shall not thereby be deemed to have consented to the proposed assignment or subletting, unless, prior to the expiration of the afores aid thirty (30) day period, Landlord shall have delivered its written consent thereto to Tenant.

 
5)
If Landlord shall cancel this Lease in whole or in part as above provided, Tenant shall surrender possession of the Demised Premises, or the portion of the Demised Premises which is the subject of the request, as the case may be, on the date set forth in such notice in accordance with the provisions of this Lease relating to surrender of the Demised Premises.  If this Lease shall be cancelled as to a portion of the Demised Premises only, (i) the Rent payable by Tenant hereunder shall be adjusted proportionately by multiplying the Rent then in effect by a fraction, the numerator of which is the number of rentable square feet in the portion of the Demised Premises to be retained and the denominator of which is the rentable square feet of the entire Demised Premises leased at the time of Tenant’s request for consent to the assignment or sublet, and (ii) Landlord, at Landlord’s expense, shall have the right to make any alterations to the Demised Premises required, in Landlord’s judgment, to make the portion of the Demised Premises surrendered a self-contained rental unit with access through corridors to any and all common areas, elevators, toilets and amenities serving such space.  At Landlord’s request, Tenant shall execute and deliver an agreement, in form satisfactory to Landlord, setting forth any modifications to this Lease contemplated or resulting from the operation of this Section;  however, neither Landlord’s failure to request such agreement nor Tenant’s failure to execute such agreement shall vitiate the effect of any cancellation pursuant to this Section.

 
6)
Notwithstanding any assignment or sublet, Tenant shall not be released from any obligation under this Lease without the express written consent of Landlord, which consent may be withheld in Landlord’s sole discretion.

26th
Access to Demised Premises.  Tenant agrees that Landlord and Landlord’s agents, employees or other representatives, shall have the right to enter into and upon the Demised Premises or any part thereof, at all reasonable hours and with reasonable notice, for the purpose of examining the same or making such repairs or alterations therein as may be necessary for the safety and preservation thereof as determined in Landlord’s sole and absolute discretion.  This clause shall not be deemed to be a covenant by Landlord nor be construed to create an obligation on the part of Landlord to make such inspection or repairs.  Landlord shall have the right to enter the Demised Premises at any time without notice to Tenant in case of emergency. In all cases of entry by Landlord, Landlord shall use commercially reasonable efforts to mi nimize disruption of Tenant’s use of the Demised Premises.

27th         Reimbursement of Landlord.
 
1)
If Tenant shall fail or refuse to comply with or perform any conditions and covenants of this Lease, Landlord may, if Landlord so elects, carry out and perform such conditions and covenants, at the cost and expense of Tenant, and the said cost and expense shall be payable on demand, or at the option of Landlord shall be added to the installment of Rent due immediately thereafter but in no case later than one (1) month after such demand, whichever occurs sooner, and shall be due and payable as such. This remedy shall be in addition to such other remedies as Landlord may have hereunder by reason of the breach by Tenant of any of the covenants and conditions contained in this Lease.

 
2)
Tenant shall pay all legal fees and expenses incurred by Landlord in (i) enforcing or modifying the terms of the Lease, (ii) commencing and prosecuting a suit for the recovery of the Demised Premises, damages or any amounts owed to Landlord, (iii) commencing and prosecuting a declaratory action, (iv) prosecuting the Landlord’s rights in any bankruptcy proceeding involving the Tenant, (v) defending an action or counterclaim brought by Tenant, (vi) preparing for or appearing in an arbitration, mediation or other non-judicial proceeding and (vii) connection with the enforcement of any post-judgment collection remedy.

28th
Late Charges, Returned Check Charges, Etc..  Tenant hereby acknowledges that late payment by Tenant to Landlord of Rent or other sums due hereunder will cause Landlord to incur costs not contemplated by this Lease, the exact amount of which will be extremely difficult to ascertain.  Accordingly:

 
1)
If any installment of Rent or any sum due from Tenant shall not be received by Landlord or Landlord's designee within seven (7) days after the due date then Tenant shall pay to Landlord a late charge equal to ten percent (10%) of such overdue amount.

 
2)
If any Tenant check deposited by Landlord is returned unpaid, Tenant shall pay to Landlord a returned check charge equal to two (2) times the amount charged to Landlord by Landlord’s Bank.

 
3)
If two (2) or more Tenant checks are returned to Landlord in any twelve (12) month period, Landlord shall have the right to require all charges due from Tenant for the balance of the Term to be paid by certified check, bank check or money order.

 
4)
If and when any installment of Rent or any sum due from Tenant has not been paid within ninety (90) days after the due date, then Landlord shall have the right from the ninety-first (91st) day forward to charge interest on Tenant’s entire unpaid balance at the rate of eight percent (8%) per annum until all Rent due from Tenant has been received by Landlord.
 
 
6

 
 
 
5)
Any such late charge, returned check charge and/or interest charge, if not previously paid, shall, at the option of the Landlord, be added to and shall become part of the succeeding rental payment to be made hereunder and shall be deemed to constitute Additional Rent.

 
6)
Late charges, returned check charges and interest charges shall be in addition to and not in lieu of any other remedy Landlord may have and is in addition to any reasonable fees and charges of any agents or attorneys Landlord may employ as a result of any default under this Lease.

29th
Default;  Remedies upon Tenant’s Default.  If there should occur any default on the part of Tenant in the performance of any conditions and cove­nants herein contained including, without limitation, the payment of Rent when due, or if during the Term hereof the Demised Premises or any part thereof shall be or become abandoned or deserted, vacated or vacant, or should Tenant be evicted by summary proceedings or otherwise, Landlord, in addition to any other remedies herein contained or as may be permitted by law, may either by force or otherwise, without being liable for prosecution therefor or for damages, re-enter the Demised Premises and have and again possess and enjoy the same; and as agent for Tenant or otherwise, re-let the Demised Premises and receive the rents therefor and apply the same, first to the payment of such expen ses, reasonable attorney fees and costs, as Landlord may have incurred in the re-entering and repossessing of the same and in making such repairs and alterations as may be necessary; and second to the payment of the Rent due hereunder. Tenant shall remain liable for such Rent as may be in arrears and also the Rent as may accrue subsequent to the re-entry by Landlord, to the extent of the difference between the Rent reserved hereunder and the Rent, if any, received by Landlord during the remainder of the unexpired term hereof, after deducting the aforementioned expenses, fees and costs; the same to be paid as such deficiencies arise and are ascertained each month.  Landlord shall have the right to elect to terminate the Term by giving notice of such election, and the effective date thereof, to Tenant and to receive Termination Damages, defined as the amount which, at the time of actual payment thereof to Landlord, is the sum of :

 
1)
all accrued but unpaid Rent;

 
2)
the present value (calculated using the most recently available (at the time of calculation) published weekly average yield on United States Treasury securities having maturities comparable to the balance of the then remaining Term) of the sum of all payments of Rent remaining due (at the time of calculation­) until the date the Term would have expired (had there been no election to terminate it earlier) less the present value (similarly calculated) of all payments of Rent to be received through the end of the Term (had there been no election to terminate it earlier) from a lessee, if any, of the Demised Premises under commercially reasonable terms existing at the time of calculation (and it shall be assumed for purposes of such calculations that (i) the amount of future Additional Rent due per year under this Agreement will be equal to the average Additional Rent per month due during the twelve (l2) calendar months immediately preceding the date of any such calculation, increasing annually at a rate of eight percent (8%) compounded; and  (ii) if any calculation is made before the end of the first full calendar year of occupancy under this Lease, operating expenses may be extrapolated based on the year-to-date experience of Landlord);

 
3)
Landlord's cost of demolishing any leasehold improvements to the Demised Premises; and

 
4)
that amount, which as of the occurrence of the default on the part of Tenant, bears the same ratio to the costs, if any, incurred by Landlord (and not paid by Tenant) in building out the Demised Premises in accordance with this Lease as the number of months remaining in the Term (immediately before the occurrence of the said default) bears to the number of months in the entire Term (immediately before the occurrence of the said default).

30th
Termination on Default.  Upon the occurrence of any of the contingencies set forth in  the 29th Section of this Lease, or should Tenant be adjudicated a bankrupt, insolvent or placed in receivership, or should proceedings be instituted by or against Tenant for bankruptcy, insolvency, receivership, agreement of composition or assignment for the benefit of creditors, or if this Lease or the estate of Tenant hereunder shall pass to another by virtue of any court proceedings, writ of execution, levy, sale or by operation of law, Landlord may, if Landlord so elects, at any time thereafter, terminate this Lease and the Term hereof, upon giving to Tenant or to any trustee, receiver, assignee or other person in charge of or acting as custodian of the assets or property o f Tenant, five (5) days notice. Upon the giving of such notice, this Lease and the Term hereof shall end on the date fixed in such notice as if the said date was the date originally fixed in this Lease for the expiration hereof; and Landlord shall have the right to remove all persons, goods, fixtures and chattels therefrom, by force or otherwise, without liability for damages.

31st
Tenant’s Right to Cure.  Anything in this Lease to the contrary notwithstanding, in the event of a default under the terms, covenants, provisions and conditions of this Lease other than the vacating by Tenant of the Demised Premises, Tenant shall have the right to cure and correct the same but only within the following specified periods next following receipt of notice from Landlord specifying said event of default:

 
1)
five (5) days with respect to defaults in the payment of Rent; and
 
 
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2)
sixty (60) days with respect to an adjudication of bankruptcy of Tenant or any assignment by Tenant for the benefit of its creditors; and

 
3)
ten (10) days with respect to all other acts of default; and if the correction of the said event of default requires the performance by Tenant of any work which cannot reasonably be performed within such time period, the said period shall be extended until said work is completed provided that Tenant commences the performance of said work and thereafter promptly and diligently pursues said work to completion.  In any such event, Tenant shall furnish Landlord with written evidence of its acts and efforts in the performance and completion of any said work and Tenant shall indemnify and hold harmless the Landlord and each mortgagee of the Property from and against any and all liabilities, damages, claims, losses, judgments, causes of action, costs and expenses (including the reasonable fees and expenses of counsel) which may be incurred by the Landl ord or any such mortgagee relating to or arising out of the Tenant's failure to complete the work within the time required hereunder.

32nd
Non-Waiver by Landlord.  The various rights, remedies, options and elections of Landlord expressed herein are cumulative, and the failure of Landlord to enforce strict performance by Tenant of the conditions and covenants of this Lease or to exercise any remedy herein conferred or the acceptance by Landlord of any installment of Rent after any breach by Tenant, in one or more instances, shall not be construed or deemed to be a waiver or a relinquishment for the future by Landlord of any such conditions, covenants, options, elections or remedies, but the same shall continue in full force and effect.

33rd
Waiver of Redemption.  Upon the expiration or sooner termination of this Lease or in the event of entry of judgment for the recovery of possession of the Demised Premises in any action or proceeding, or if Landlord shall enter the Demised Premises by process of law or otherwise, Tenant, for itself and all persons claiming through or under Tenant, including, but not limited to, its creditors, hereby waives and surrenders any right or privileges of redemption provided or permitted by any statute, law or decision now or hereafter in force, to the extent legally authorized, and does hereby waive and surrender all rights or privileges which it may or might have under and by reason of any present or future law or decision, to redeem the Demised Premises or for a continuation of this Lease after having been dispossessed or ejected therefrom by process of la w, or otherwise.  Such expiration or termination shall not release or discharge any obligation of Tenant to pay Rent or any other liability incurred by reason of any covenant herein contained on the part of Tenant to be performed.

34th         Not Used.

35th
Limitations.  Any claim, demand, right or defense by Tenant that arises out of this Lease, or the negotiations that preceded this Lease, shall be barred unless Tenant commences an action thereon, or interposes a defense by reason thereof, within six (6) months after the date of the inaction, omission, event or action that gave rise to such claim, demand, right or defense.  Tenant acknowledges and understands, after having consulted with its legal counsel, that the purpose of this Section is to shorten the period within which Tenant would otherwise have to raise such claims, demands, rights or defenses under applicable Laws.

36th
Not Used.

37th
Not Used.

38th
Casualty Insurance. Landlord shall carry insurance for fire, extended coverage, vandalism, malicious mischief and other endorsements deemed advisable by Landlord, insuring all improvements on the Property, including the Demised Premises and all leasehold improvements thereon and appurtenances thereto (excluding Tenant's merchandise, trade fixtures, furnishings, equipment and personal property) for the full insurable value thereof, with such deductibles as Landlord deems advisable.  The cost of such insurance shall be included in Operating Expenses.

39th
Right to Exhibit.  Tenant agrees from time to time to permit Landlord and Landlord’s agents, employees or other representatives to enter and show the Demised Premises to persons wishing to rent or purchase the same, and Tenant agrees that on and after six (6) months next preceding the expiration of the Term, Landlord or Landlord’s agents, employees or other representatives shall have the right to place notices on the front of the Property or the Demised Premises or any part thereof, offering the same for rent or for sale; and Tenant hereby agrees to permit the same to remain thereon without hindrance or molestation.

40th
Mortgage Priority.  This Lease shall not be a lien against the Property in respect to any mortgages that may hereafter be placed upon said Property.  This Lease is subject and subordinate to all ground or underlying leases and to all mortgages that may now or hereafter affect the Property, including all renewals, modifications, consolidations, replacements and extensions of any such underlying leases and mortgages.  The recording of any such mortgage or mortgages shall have preference and precedence and be superior and prior in lien to this Lease, irrespective of the date of recording.  This clause shall be self-operative and no further instrument of subordination shall be required by any ground lessor or by any mortgagee in order to effectuate such subordination.
 
 
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41st
Certification.  Tenant shall, without charge, and at any time during the Term execute and promptly deliver to Landlord or its agent, within ten (10) days after written request from Landlord or its agent, as the case may be, its certification as to:  (i) whether this Lease has been modified or amended, and if so, the date, substance and manner of such modification or amendment; (ii) as to the validity and force and effect of this Lease; (iii) as to the existence of any default hereunder, and if so, the nature, scope and extent thereof; (iv) as to the existence of any offsets, counterclaims or defenses on the part of Tenant, and if so, the nature, scope and extent thereof; (v) as to the commencement and termination dates of the Term; (vi) as to the dates to which Rent has been paid; (vii) such financial and other credit information as Landlor d may reasonably request in connection with any prospective financing or sale of the Demised Premises or the Property; and (viii) as to any other matters as may reasonably be so requested.  Any such certificate may be relied upon by Landlord and any other person, firm or corporation to whom the same may be exhibited or delivered, and Tenant shall be bound by the contents of such certificate.  A refusal by Tenant to execute and deliver such certificate in accordance with the provisions of this Section shall entitle Landlord to the option of canceling this Lease on five (5) days notice.
 
42nd
Attornment.  Neither the foreclosure of any mortgage affecting the Demised Premises, nor the institution of any suit, action, summary, or other proceeding by Landlord or any mortgagee, nor the sale, conveyance or transfer of the Demised Premises by Landlord, shall result, by operation of law or otherwise, in the cancellation or termination of this Lease or the obligations of Tenant hereunder, and Tenant covenants and agrees to attorn to Landlord, the holder of any mortgage, or the purchaser, grantee, or transferee of the Demised Premises.

43rd
Condemnation and Eminent Domain.  If the land and Property of which the Demised Premises are a part, or any portion thereof, shall be taken under eminent domain or condemnation proceedings, or if suit or other action shall be instituted for the taking or condemnation thereof, or in lieu of any formal condemnation proceedings or actions, Landlord shall grant an option to purchase and or shall sell and convey the Property or any portion thereof, to the governmental or other public authority, agency body or public utility seeking to take the Property or any portion thereof, then this Lease, at the option of Landlord, shall terminate, and the Term hereof shall end as of such date as Landlord shall fix by notice in writing as if such date were the date designated as the last day of the Term set forth above; and Tenant shall have no claim or right to claim or be entitled to any portion of any amount which may be awarded as damages or paid as the result of such condemnation proceedings or paid as the purchase price for such option, sale or conveyance in lieu of formal condemnation proceedings; and all rights of Tenant to damages, if any, are hereby assigned to Landlord. Tenant agrees to execute and deliver any instruments promptly upon demand, at the expense of Landlord, as may be deemed necessary or required to expedite any condemnation proceedings or to effectuate a proper transfer of title to such governmental or other public authority, agency, body or public utility seeking to take or acquire the Property or any portion thereof.  Tenant covenants and agrees at its sole cost and expense to vacate the Demised Premises, remove all Tenant’s personal prop­erty therefrom and deliver up peaceable possession thereof to Landlord or to such other party designated by Landlord in the aforementioned notice.  Failure by Tenant to comply wi th any provisions in this clause shall subject Tenant to such costs, expenses, damages and losses as Landlord may incur by reason of Tenant’s breach hereof including, without limitation, attorneys’ fees.

44th
Fire and other Casualty.  In case of fire or other casualty affecting the Demised Premises, Tenant shall give immediate notice to Landlord or, in case of fire or other casualty affecting the Property other than the Demised Premises, Tenant shall give immediate notice to Landlord upon Tenant obtaining knowledge of such fire or casualty.  If the Demised Premises shall be partially damaged by fire, the elements or other casualty, Landlord shall repair the same as speedily as practicable, but Tenant’s obligation to pay the Rent hereunder shall not cease.  If, in the opinion of Landlord, the Demised Premises is so exten­sively and substantially damaged as to render them untenantable, then the Rent shall cease until such time as the Demised Premises shall be made tenantable by Landlord.  However, if, in the opinion of Landlord, the Demised Premises is totally destroyed or so extensively and substantially damaged as to require practically a rebuilding thereof, then the Rent shall be paid up to the time of such destruction and then and from thenceforth this Lease shall automatically and without notice come to an end.  In no event however, shall the provisions of this clause become effective or be applicable, if the fire or other casualty and damage shall be the result of the carelessness, negligence or improper conduct of Tenant or Tenant’s agents, employees, guests, licensees, invitees, subtenants, assignees or successors.  In such case, Tenant’s liability for the payment of the Rent and the performance of all the cov­enants, conditions and terms hereof on Tenant’s part to be performed shall continue and Tenant shall be liable to Landlord for the damage and loss suffered by Landlord.  If Tenant shall have been insured against any of the risks herein covered, then the proceeds of such insurance shall be paid over to Landlord to the extent of Landlord’s costs and expenses to make the repairs hereunder, and such insurance carriers shall have no recourse against Landlord for reimbursement.

45th
Liability Insurance.  Tenant, at Tenant’s sole cost and expense, shall obtain or provide and keep in full force and effect for the benefit of Landlord, during the Term, commercial general liability insurance, insuring Landlord against any and all liability or claims of liability arising out of, occasioned by or resulting from any accident or otherwise in or about the Demised Premises, for injuries to any person or persons, for limits of not less than One Million and 00/100 Dollars ($1,000,000.00) for injuries to one person and Two Million and 00/100 Dollars ($2,000,000.00) for injuries to more than one person, in any one accident or occurrence, for not less than One Million and 00/100 Dollars ($1,000,000.00) for loss or damage to the property of any person or persons.  The policy or policies of insurance shall be of a company or compa nies authorized to do business in the State in which the Property is located and shall be delivered to Landlord, together with evidence of the payments of the premiums therefor, not less than fifteen (15) days prior to the commencement of the Term hereof or of the date when Tenant shall enter into possession, whichever occurs sooner.  At least fifteen (15) days prior to the expiration or termination date of any policy, Tenant shall deliver a renewal or replacement policy with proof of the payment of the premium therefor. Landlord shall obtain and maintain during the Term, commercial general liability insurance against claims for bodily injury, personal injury, death or property damage occurring on, in or about the Property or as a result of ownership of the facilities located in the Property for limits of not less than One Million and 00/100 Dollars ($1,000,000.00) for injuries to one person and Two Million and 00/100 ($2,000,000.00) for injuries to more than one person in any one accident or occur rence, for not less than One Million and 00/100 Dollars ($1,000,000.00) for loss or damage to the property of any person or persons.  Such policy shall include a contractual liability endorsement and shall cover Landlord's indemnity obligation described in Section 47.  The cost of such insurance shall be included in Operating Expenses.  The amount of insurance to be carried by Landlord shall be an amount Landlord deems reasonably necessary or appropriate in connection with the use and operation of the Property and customarily carried with respect to similar properties in Middlesex County, New Jersey or as any mortgagee of Landlord may require.
 
 
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46th
Tenant’s Indemnity.  Tenant, at its sole cost and expense agrees to and shall indemnify, defend and hold and keep harmless Landlord and its agents, representatives, employees, constituent members, successors and assigns, from and against any and all claims, actions, demands and suits, for, in connection with or resulting from any accident, injury or damage whatsoever (including, without limitation, reasonable attorneys’ fees and actual out-of-pocket costs of enforcement of this provision) caused to any person or property arising, directly or indirectly, in whole or in part, out of the business conducted in or the use of the Demised Premises, or occurring in, on or about the Demised Premises, or arising, directly or indirectly, in whole or in part, from any act or omission of Tenant or any concessionaire or subtenant or their respective li censees, servants, agents, employees or contractors, or arising out of the breach or default by Tenant of any term, provision, covenant or condition contained in the Lease, and from and against any and all losses, costs, expenses, judgments and liabilities incurred in connection with any claim, action, demand, suit or other proceeding brought thereon.  This indemnity shall include defending or resisting any proceeding, by attorneys reasonably satisfactory to Landlord.  This indemnity shall be insured as a contractual obligation under the policy of liability insurance Tenant is required to carry hereunder.

47th
Landlord’s Indemnity.  Landlord, at its sole cost and expense agrees to and shall indemnify, defend and hold and keep harmless Tenant and its agents, representatives, employees, constituent members, successors and assigns, from and against any and all claims, actions, demands and suits, for, in connection with or resulting from any accident, injury or damage whatsoever (including, without limitation, reasonable attorneys’ fees and actual out-of-pocket costs of enforcement of this provision) caused to any person or property arising from any negligence or willful misconduct of Landlord or its respective licensees, servants, agents, employees or contractors, except to the extent due to the negligence or willful misconduct of Tenant.

48th
Tenant’s Contents Insurance.  Tenant shall hold Landlord harmless and fully indemnify Landlord against any claims for damages to Tenant’s contents, except in the case of subrogation by an insurance company.  In addition to all other insurance required hereunder, Tenant shall fully insure its contents located in, on or about the Demised Premises, at full replacement value.  Tenant shall furnish Landlord with a certificate of such insurance from time to time to evidence the continued existence of said policy.  Said certificate shall clearly state that such insurance may not be cancelled except upon ten (10) days written notice to Landlord.  Should Tenant at any time fail to maintain said contents  coverage, said failure shall not be a default hereunder but shall constitute a defacto waiver o f all rights of recovery against Landlord for any loss or damage of any nature whatsoever to Tenant's property regardless of the cause of said damage.

49th
Exculpation.  Notwithstanding anything to the contrary set forth in this Lease, it is specifically understood and agreed by Tenant that there shall be absolutely no personal liability on the part of Landlord or any individuals associated with Landlord, including, but not limited to, any partners, members or shareholders of Landlord nor joint venturers with Landlord nor any of their successors, assignees, heirs, executors, administrators or personal and legal representatives with respect to any of the terms, covenants and conditions of this Lease, and Tenant shall look solely to the equity, if any, of Landlord in the Property for the satisfaction of each and every remedy (including, without limitation, equitable remedies) of Tenant in the event of any breach by Landlord of any of the terms, covenants and conditions of this Lease to be performed by Lan dlord; such exculpation of personal liability to be absolute and without any exception whatsoever.

50th
Non-Liability of Landlord.  Neither Landlord nor any of its agents, co-venturers, representatives, employees, constituent members, successors or assigns shall be liable for any damage or injury which may be sustained by Tenant or by any other person, nor shall Tenant have any right to claim an eviction or constructive eviction as a consequence of: (i) any defect, latent or apparent in the Demised Premises; or (ii) any change of conditions in the Demised Premises; or (iii) the failure, breakage, leakage or obstruction of the street or sub-surface; or (iv) the failure, breakage, leakage or obstruction of the water, plumbing, steam, sewer, waste or soil pipes; or (v) the failure, breakage, leakage or obstruction of the roof, walls, drains, leaders, gutters, valleys, downspouts or the like; or (vi) the failure, breakage, leakage or obstruction of the ele ctrical, gas, power, conveyor, refrigeration, sprinkler, air conditioning or heating systems; or (vii) the failure, breakage, leakage or obstruction of  elevators or hoisting equipment; or (viii) any structural failure; or (ix) the elements; or (x) any theft or pilferage; or (xi) any fire, explosion or other casualty; or (xii) the carelessness, negligence or improper conduct on the part of  any other tenant or of Landlord, or Landlord’s or this or any other tenant’s respective agents, employees, guests, licensees, invitees, subtenants, assignees or successors; or (xiii) any interference with, interruption of or failure, beyond the control of Landlord, of any services to be furnished or supplied by Landlord.  All property kept, maintained or stored in, on or at the Demised Premises shall be so kept, maintained or stored at the sole risk of Tenant.

51st
Increase of Insurance Rates.  If for any reason it shall be impossible to obtain fire and other hazard insurance on the buildings and improvements on the Property, in an amount and in the form and in insurance companies acceptable to Landlord, Landlord may, if Landlord so elects at any time thereafter, terminate this Lease and the Term hereof, upon giving to Tenant fifteen (15) days’ notice, and upon the giving of such notice, this Lease and the Term thereof shall terminate and end as of the date set forth in said notice as if such date were the date designated as the last day of the Term set forth above.  If by reason of the use to which the Demised Premises are put by Tenant or character of or the manner in which Tenant’s business is carried on, the insurance rates for fire and other hazards shall be increased, Tenant shall up on demand, pay to Landlord, as Additional Rent, the amount by which the premiums for such insurance are increased.  Such payment shall be paid with the next installment of Rent but in no case later than one (1) month after such demand, whichever occurs sooner.
 
 
10

 
 
52nd
Waiver of Subrogation Rights.  Tenant and Landlord waive all rights of recovery against each other and each other’s agents, employees or other representatives, for any loss, damages or injury of any nature whatsoever to property or persons for which Tenant or Landlord is insured.  Tenant shall obtain from Tenant’s insurance carriers, and shall promptly deliver to Landlord, waivers of subrogation rights under its respective policies required hereunder.

53rd
No Broker.  Tenant and Landlord warrant that they have not dealt with any real estate broker in connection with negotiations for, or execution of, this Lease.  In the event of any misrepresentation by either Tenant or Landlord, the misrepresenting party agrees to hold the other harmless from any costs or claims, including, without limitation, reasonable attorneys’ fees.

54th
Notices.  Any and all notices, requests or other such communications required under the terms of this Lease shall be given either (i) by certified or registered mail, return receipt requested, postage prepaid, or (ii) a national overnight delivery service with receipt provided therefor, prepaid, to the address of the parties as shown at the head of this Lease or to such other address as may be designated in writing, which notice of change of address shall be given in the same manner.  Notice shall be deemed effective if by mail, on the third (3rd) business day after mailing thereof, and if by overnight delivery, on the next business day after deposit or pick-up by such overnight delivery service.

55th
Force Majeure.  Except for Tenant’s obligation to pay rent, the period of time during which Landlord or Tenant is prevented or delayed in performing any improvements or repairs or fulfilling any obligation required by Landlord or Tenant under this Lease due to delays caused by reason of fire, catastrophe, strikes or labor trouble, civil commotion, acts of God or the public enemy, governmental prohibitions or regulations, or inability or difficulty in obtaining materials, or other causes beyond Landlord’s or Tenant’s control, as the case may be, shall be added to Landlord’s or Tenant’s time for performance thereof, and Landlord or Tenant shall have no liability by reason thereof.

56th
Rules and Regulations.  Rules and regulations regarding use of the Demised Premises and the Property, including the walkways and parking areas, and the use thereof, which may hereafter be promulgated by Landlord from time to time, shall be observed by Tenant and Tenant’s employees, agents and business invitees.  Landlord reserves the right to rescind any rules promulgated hereafter, and to make such other and further rules and regulations as, in its reasonable judgment, may from time to time be desirable for the safety and cleanliness of the Demised Premises and the Property and for the preservation of good order therein, which rules, when so made, and notice given to Tenant, shall have the same force and effect as if originally made a part of this Lease.

57th
Validity of Leases.  The terms, conditions, covenants and provisions of this Lease shall be deemed to be severable.  If any clause or provision herein contained shall be adjudged to be invalid or unenforceable by a court of competent jurisdiction or by operation of any applicable law, it shall not affect the validity of any other clause or provision herein, but such other clauses or provisions shall remain in full force and effect.

58th
Title and Quiet Enjoyment.  Landlord covenants and represents that Landlord is the sole owner of the Property herein leased and has the right and authority to enter into, execute and deliver this Lease; and does further covenant that Tenant on paying the Rent and performing the conditions and covenants herein contained, shall and may peaceably and quietly have, hold and enjoy the Demised Premises for the Term.

59th
Entire Lease.  This Lease contains the entire contract between the parties hereto.  No representative, agent or employee of Landlord has been authorized to make any representations or promises with reference to the within letting or to vary, alter or modify the terms hereof.  No additions, changes or modifications, renewals or extensions hereof shall be binding unless made in writing and signed by Landlord and Tenant.

60th
Lease Submission.  If this Lease is offered to Tenant by an employee or agent of the Landlord, such offer is made subject to Landlord’s acceptance and approval; and Tenant has executed this Lease upon the understanding that this Lease shall not in any way bind Landlord until such time as the same has been approved and executed by Landlord and a counterpart delivered to or received by Tenant.

61st
Conformation with Laws and Regulations. Landlord may pursue the relief or remedy sought in any invalid clause in this Lease, by conforming the said clause with the pro­visions of the statutes or the regulations of any governmental agency in such case made and provided, as if the particular provisions of the applicable statutes or regulations were set forth herein at length.

62nd
Recordation.  Tenant covenants and agrees not to place this Lease on record without the consent of Landlord, which consent may be withheld for any reason.
 
 
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63rd
Waiver of Trial by Jury.  THE PARTIES HEREBY WAIVE TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM BROUGHT BY EITHER OF THE PARTIES HERETO AGAINST THE OTHER ON ANY MATTERS WHATSOEVER ARISING OUT OF OR IN ANY WAY CONNECTED TO THIS LEASE, THE RELATIONSHIP OF LANDLORD AND TENANT, TENANT’S USE OR OCCUPANCY OF THE DEMISED PREMISES, AND/OR CLAIM OF INJURY OR DAMAGE.

64th
Jurisdiction.  This Lease shall be construed and interpreted in accordance with the substantive and procedural laws of the State of New Jersey.

65th
Headings.  The descriptive headings of the Sections of this Lease are inserted for convenience only and shall not control or affect the meaning or construction of any of its provisions.

66th
Gender, etc.  In all references herein to any parties, persons, entities or corporations the use of any particular gender or the plural or singular number is intended to include the appropriate gender or number as the text of the within instrument may require.

67th
Succession.  All the terms, covenants and conditions herein contained shall be for and shall inure to the benefit of and shall bind the respective parties hereto, and their heirs, executors, administrators, personal or legal representatives, successors and assigns.

68th
Consents.  With respect to any provision of this Lease which requires that Landlord shall not unreasonably withhold or unreasonably delay any consent or approval, Tenant hereby waives any claim for money damages.  Tenant shall not claim any money damages by way of setoff, counterclaim or defense based upon any claim or assertion by Tenant that Landlord has unreasonably withheld or unreasonably delayed any consent or approval.  Tenant’s sole and exclusive remedy shall be an action or proceeding for specific performance or injunction.

69th
Holding Over.  Any holding over or continued occupancy by Tenant after the Expiration Date (other than as may have been provided for in this Lease or in amendments executed in accordance with the 34th Section of this Lease) shall not operate to extend or renew this Lease or to imply or create a new lease.  In such event, Landlord shall have the right to immediately terminate Tenant’s occupancy or to treat Tenant’s occupancy as a month-to-month tenancy, in which event Tenant shall continue to perform all Lease obligations, including the payment of Base Rent at a rate equal to two hundred percent (200%) of the Base Rent as shall be in effect immediately prior to the termination of the Term hereof.& #160; In no event however, shall Tenant be relieved of any liability to Landlord for damages resulting from such holding over.  If the Demised Premises is not surrendered as required, Tenant shall indemnify, defend and hold harmless Landlord from and against any and all damages, losses and liabilities resulting therefrom, including, without limitation, any claims made by any succeeding tenant arising out of such delay.  Tenant’s obligation under this Section shall survive the expiration or sooner termination of this Lease.

70th         Landlord’s Representations.  Landlord hereby warrants and represents to Tenant that:

 
1)
Landlord has full power and authority to enter into this Lease and the person executing this Lease on behalf of Landlord is authorized to do so.

 
2)
Landlord has received no notice of any material violations affecting the Demised Premises or the Property.

 
3)
Landlord has received no notice of any spills, releases, leaks or discharges of Hazardous Substances, as defined in Exhibit C attached hereto and made a part hereof, at or from the Demised Premises.

 
4)
The certificate of occupancy issued for the Property permits Tenant to use the Demised Premises for the purposes permitted under this Lease.

 
5)
As of the Commencement Date, the Demised Premises are free from all occupancies or tenancies whatsoever.

 
6)
No other tenant or occupant of the Property has been granted a right which would prohibit or limit the Use permitted to Tenant under this Lease.

 
7)
All utilities installed in the Demised Premises are in good working order as of the date hereof.
 
 
12

 

 
IN WITNESS WHEREOF, the parties hereto have hereunto set their hands and seals, or caused these pres­ents to be signed by their proper corporate officers or other duly authorized representatives and their proper corporate seal (if applicable) to be hereto affixed, as of the day and year first above written.
 
WITNESS:   LANDLORD  
   
Princeton Corporate Plaza, LLC
 
   
By:
Princeton Corporate Management Corp.,  
      Managing Member  
         
         
/s/ Pamela Kent   By: /s/ Teresa Ryan Kent   
    Name: Teresa Ryan Kent  
9/28/2010   Title: Treasurer   
Date         
         
    TENANT  
WITNESS:    Tamir Biotechnology, Inc.  
         
         
         
         
    By: /s/ Charles Muniz   
    Name: Charles Muniz  
________   Title: 9-13-10  
Date        
         
 
 
13

 
EXHIBIT A

Demised Premises

 
14

 
EXHIBIT A-1

Workletter Drawing – Floor Plan
 

 
 
15

 
 
EXHIBIT A-2

Workletter Drawing – Outlets
 
 
 
16

 
 
EXHIBIT A-3

Workletter Drawing – Ceiling Plan
 
 
 
17

 

EXHIBIT B

Description of Landlord's Work

All Special requirements of Tenant that are not included in this Exhibit shall be at the sole cost and expense of Tenant.


1.    FLOORING:
 
 
Office Area:
Existing carpet, patched for open area created by demolishen of walls.  Raised Floor with vinyl tile in computer equipment room.
 
Laboratory:
Existing vinyl tiles
   
2.    PARTITIONS:
 
 
Office Area:
As shown on Exhibit A-1 Floor Plan
   
except for the items set forth in Exhibit B-1 “Description of Tenant’s Work”
 
Laboratory:
As shown on Exhibit A-1 Floor Plan
 
except for the items set forth in Exhibit B-1 “Description of Tenant’s Work”
   
3.    ELECTRICAL:
 
 
Office Area:
As shown on Exhibit A-2 Outlet Plan
   
except for the items set forth in Exhibit B-1 “Description of Tenant’s Work”
 
Laboratory:
As shown on Exhibit A-2 Outlet Plan
 
except for the items set forth in Exhibit B-1 “Description of Tenant’s Work”
 
All outlets are 110v unless otherwise specified on Exhibit A-2. Special Electric by Tenant.
   
4.    LIGHTING:
 
 
Office Area:
As shown on Exhibit A-3 Ceiling Plan
   
except for the items set forth in Exhibit B-1 “Description of Tenant’s Work”
 
Laboratory:
As shown on Exhibit A-3 Ceiling Plan
 
except for the items set forth in Exhibit B-1 “Description of Tenant’s Work”
   
5.    CEILINGS:
 
 
Office Area:
As shown on Exhibit A-3 Ceiling Plan
   
except for the items set forth in Exhibit B-1 “Description of Tenant’s Work”
 
Laboratory:
As shown on Exhibit A-3 Ceiling Plan
 
except for the items set forth in Exhibit B-1 “Description of Tenant’s Work”
   
6.    WALL FINISH:
 
 
Office Area:
Painted, one color.
 
Laboratory:
Painted, one color.
   
7.    INTERIOR DOORS:
 
Office Area:
As shown on Exhibit A-1 Floor Plan
   
except for the items set forth in Exhibit B-1 “Description of Tenant’s Work”
 
Laboratory:
As shown on Exhibit A-1 Floor Plan
 
except for the items set forth in Exhibit B-1 “Description of Tenant’s Work”
   
8.    PLUMBING:
Hot and cold water connections to laboratory sinks.  Cold water connection to fume hood.  Installation of tenant supplied DI Water system.  Installation of tenant supplied autoclave.  Installation of tenant supplied ice machine in location to be determined.
   
9.    HEATING & AIR CONDITIONING:
Cooling 78 degrees at 95 degrees.
Heating 68 degrees at 0 degrees.
   
10.  FIRE EXTINGUISHERS:
As per Township code.
   
11.  SPRINKLERS:
As per Township code.
 
12.  LABORATORY EQUIPMENT & FURNISHINGS:  Three (3) Laboratory Sinks, One (1) Fume Hood.  Cabinets and benches per exhibit A-1 Floor Plan.
 
 
18

 
 
EXHIBIT B-1

Description of Tenant’s Work

Fit-out Costs by Tenant:

All special requirements not included in Exhibit B will be at Tenant cost.

The following are included in the cost specified in the 11th Section of the Lease:

 

Telephone, Data, Communications:
 
   Equipment and Installation
By Tenant
   
   
   
   
   
   
   
   
   
   

 
19

 

EXHIBIT C

ENVIRONMENTAL MATTERS

I.             NAICS

Tenant warrants and represents to the Landlord that the North American Industrial Classification System (“NAICS”) major group number, as defined in the most recent issue of the NAICS Manual issued by the Federal Office of Management and Budget, for Tenant’s operations at the Demised Premises is ______ .  Prior to any proposed changes of such NAICS Number, Tenant will notify Landlord.

II.            ISRA

 
1.
Tenant shall not operate any business at the Demised Premises which shall have an NAICS which is subject to the  Industrial Site Recovery Act,  N.J.S.A. 13:1K-6 et seq. and the regulations promulgated thereunder (hereinafter referred to as “ISRA”), nor shall Tenant change its use to any other use subject to ISRA without Landlord’s prior written consent, which may be withheld in Landlord’s sole discrection.

 
2.
Notwithstanding any provision of ISRA to the contrary, if Tenant is operating an “Industrial Establishment”, as that term is defined in ISRA, Tenant shall, at Tenant's own expense, comply with ISRA and the regulations promulgated thereunder.  In such event Tenant shall, at Tenant's own expense make all submissions to, provide all information to, and comply with all requirements of the State of New Jersey, Department of Environmental Protection (hereinafter referred to as the “NJDEP”). At no expense to Landlord, Tenant shall promptly provide all documents, studies, surveys, correspondence and other information requested by Landlord relating to or in furtherance of ISRA compliance.

 
3.
Tenant's obligations under this Exhibit C shall arise if there is any closing, termination or transferring of operations of an industrial establishment subject to ISRA. At no expense to Landlord, Tenant shall promptly provide all information requested by Landlord for preparation of non-applicability affidavits and shall promptly furnish such affidavits when requested by Landlord.

 
4.
Tenant shall indemnify, defend and save harmless Landlord from all fines, fees (including reasonable attorney's fees), suits procedures, claims, and actions of any kind arising out of Tenant's failure to provide all information, make all submissions, and take all actions required under ISRA or by the NJDEP.

 
5.
Tenant's obligations and liabilities under this Section of Exhibit C shall continue so long as Landlord remains responsible for compliance with ISRA. Tenant's failure to abide by the terms of this Section shall be restrained by injunction and such other relief as afforded by law.
 
III.           HAZARDOUS SUBSTANCES

 
1.
As used herein, Hazardous Substances shall be defined as

 
a.
any “hazardous chemical”, “hazardous substances”, “hazardous waste”, “toxic substances, pollutants or contaminants” or similar term as defined in the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (“CERCLA”), 42 U.S.C.A. 9601 et seq., ISRA, the New Jersey Spill Compensation and Control Act (the “Spill Act”), as amended, N.J.S.A. 58:10-23. 1lb et seq. (Regulations N.J.A.C. 7:1E-1.1 et seq.), the Solid Waste Management Act, N.J.S.A. 13:1E-1 et seq. (Regulations N.J.A.C. 7:26-1 et seq.), the Resource Conservation and Recovery Act (“RCRA”), 42 U.S.C.A. 6901 et seq., any rules or regulations promulgated thereunder or in any other Environmental Law, as defined in this Lease; or

 
b.
any substances which are or could be detrimental to the Demised Premises, the Property, the environment, human health or safety; or

 
c.
any substance the presence of which could cause liability at common law; or

 
d.
any substance that may not be deemed to be a hazardous substance in its virgin state prior to use by the Tenant but may thereafter be deemed to be a hazardous substance.

 
2.
As used herein, Release of Hazardous Substances by Tenant shall be defined as the spill, release, discharge or leak of any Hazardous Substances

 
a.
onto the Demised Premises from the date Tenant first took possession of the Demised Premises until the date Tenant has completely vacated the Demised Premises; or

 
b.
onto the Property at any time resulting from Tenant’s intentional or unintentional act or omission.
 
 
20

 
 
 
3.
Tenant agrees not to generate, store, manufacture, refine, transport, treat, dispose of or otherwise permit to be present on or about the Demised Premises and/or the Property any Hazardous Substances without the prior express written consent of the Landlord, and the parties acknowledge that no such consent has been given as of the date hereof except that the Landlord hereby expressly consents to Tenant’s use and/or storage of any and all of the Hazardous Substances set forth in the Tenancy Review, provided, however, that the quantities thereof shall be limited to the amounts set forth in the Tenancy Review.  In the event that the Landlord has given its consent and to the extent that Tenant may be permitted under applicable law to use the Demised Premises for the generating, manufacturing, refining, transporting, treating, storing, handl ing, disposing, transferring or processing of Hazardous Substances, Tenant shall insure that said use shall be conducted at all times strictly in accordance with Environmental Laws.

 
4.
Tenant will not cause or permit any Release of Hazardous Substances by Tenant.  In the event of any Release of Hazardous Substances by Tenant, Tenant shall promptly make the proper notifications and conduct the necessary sampling and cleanup and remediate such release in accordance with Environmental Laws, to the satisfaction of the Landlord.

 
5.
Should the NJDEP or any other agency with jurisdiction under any Environmental Laws determine that any investigation or remediation be undertaken because of any Release of Hazardous Substances by Tenant, then Tenant shall, at Tenant’s own expense, conduct the investigation and remediation including, but not limited to, the preparation and submission of any documents and financial assurances that may be required by such agency.  Tenant shall not be liable for the cost of that portion of the remediation which is solely related to Hazardous Substances existing on the Demised Premises prior to the date Tenant first took possession of the Demised Premises.

 
6.
Tenant's obligations and liabilities under this Section of Exhibit C shall continue so long as Landlord remains responsible for any Release of Hazardous Substances by Tenant at the Demised Premises. Tenant's failure to abide by the terms of this Section shall be restrained by injunction and such other relief as afforded by law.

IV.           AIR, WATER AND GROUND POLLUTION

 
1.
Tenant shall not install any underground or aboveground storage tanks at or on the Demised Premises or the Property without Landlord’s written consent, which may be withheld in Landlord’s sole discretion.

 
2.
Tenant expressly covenants and agrees to indemnify, defend and save the Landlord  harmless against any claims, damages, liability, costs, penalties, or fines including, without limitation, reasonable attorneys’ fees, which the Landlord may suffer as a result of air, water, ground or toxic waste pollution (hereinafter referred to as “Pollution”) caused by the Tenant in its use of the Demised Premises.  The Tenant covenants and agrees to notify the Landlord immediately of any claim or notice served upon it with respect to any such claim that the Tenant is causing Pollution; and the Tenant, in any event, shall take immediate steps to halt, remedy or cure any Pollution caused by the Tenant in its use of the Demised Premises. The foregoing covenant of indemnification shall survive the termination of this Lease in connection with any obligation of the Tenant hereunder.

V.            INSPECTION AND DOCUMENTATION

 
1.
At any time upon request of Landlord, Tenant must give Landlord and its representatives access to the Demised Premises during normal business hours to permit them to inspect the Demised Premises, inspect any documents pertaining to Tenant’s compliance with Environmental Laws, or perform any work in order to determine that the Demised Premises and its use by Tenant is in compliance with Environmental Laws, all at Tenant’s expense, payable as Additional Rent.

 
2.
Tenant shall promptly provide to Landlord a copy of any summons, citation, directive, order, claim, notice of litigation, investigation, proceeding, judgment, letter or other communication, written or oral, actual or threatened, from the NJDEP, the U.S. Environmental Protection Agency or other federal, state or local agency or authority or any other entity or any individual, concerning any act or omission by Tenant resulting in or which may result in the releasing of Hazardous Substances into the waters or onto the lands of the State of New Jersey or into waters outside of the jurisdiction of the State of New Jersey or into the “Environment” as defined in CERCLA. Written notice to Landlord shall also be made upon the imposition of any liens on any real property, personal property, or revenues of the Tenant, including but not limited to the Tenan t's interest in a premises or any of the Tenant's property located thereupon, pursuant to the Spill Act or any Environmental Laws, governmental actions, orders or permits or any knowledge after due inquiry or investigation of any facts which could give rise to any of the above.

 
3.
In addition to the above, the Tenant’s notifications to the Landlord shall include but be not limited to all documentation and correspondence provided to the NJDEP pursuant to the Worker and Community Right-to-Know Act, N.J.S.A. 34:5A-1 et seq., and the regulations promulgated thereunder;
 
 
21

 
 
 
4.
Tenant shall promptly supply the Landlord with all reports and notices made by Tenant pursuant to the Spill Act, the regulations provided thereunder, and the Hazardous Substances Discharge Reports and Notices Act, N.J.S.A 13:1K-15 et seq., and the regulations promulgated thereunder .

 
5.
Tenant shall promptly provide Landlord with a copy of any permit obtained for the Demised Premises pursuant to any Environmental Law.

VI.           CONTINUING OBLIGATIONS AND INDEMNITY

 
1.
Notwithstanding the expiration or earlier termination of this Lease, if at any time during Tenant’s occupancy of the Demised Premises, Tenant has operated an Industrial Establishment, as that term is defined in ISRA, then Tenant shall have a continuing obligation to pay to Landlord the amount established under this Lease as Rent plus the difference between such Rent and the fair market rental value of the Demised Premises, if greater than the established Rent, for the period after expiration or earlier termination of this Lease until such time as the Tenant obtains and delivers to the Landlord a Negative Declaration or No Further Action Letter as defined in ISRA, or such other proof, reasonably satisfactory to the Landlord, that the Tenant has complied with  ISRA.

 
2.
Notwithstanding the expiration or earlier termination of this Lease, if there exists a violation of Environmental Laws at the Demised Premises which did not exist prior to the date Tenant first took possession of the Demised Premises or if Tenant has failed to fulfill its obligations under this Exhibit C, Tenant shall have a continuing obligation to pay to Landlord the amount established as Rent under this Lease plus the difference between such Rent and the fair market rental value of the Demised Premises, if greater than the established Rent, for the period after expiration or earlier termination of this Lease until the applicable governmental entities confirm, in writing, that the violation of Environmental Laws has been cured and that Tenant has fulfilled its obligation under Environmental Laws and under this Exhibit C.

 
3.
If a lien shall be filed against the Demised Premises arising in whole or in part out of (i) any Release of Hazardous Substances by Tenant, or (ii) the violation of Environmental Laws by Tenant, then Tenant shall pay the claim and remove the lien from the Demised Premises within thirty (30) days from the date Tenant is given notice of the lien or within such shorter period of time as may be required if the United States, the State of New Jersey, or any agency or subdivision of either such entity has commenced steps to cause the Demised Premises or the Property to be sold pursuant to the lien.  Tenant shall not be responsible for any portion of the lien which is related to a spill, release, leak or discharge of Hazardous Substances which occurred prior to the date Tenant first took possession of the Demised Premises.

 
4.
Tenant shall indemnify and hold harmless the Landlord and each mortgagee of the Property from and against any and all liabilities, damages, claims, losses, judgments, causes of action, costs and expenses (including the reasonable fees and expenses of counsel) which may be incurred by the Landlord or any such mortgagee relating to or arising out of the Tenant's generation, storage, manufacturing, refining, transportation, treatment, disposal, or other presence of Hazardous Substances on or about the Demised Premises and/or the Property or any Release of Hazardous Substances by Tenant or the Tenant's failure to comply with the provisions of this Exhibit C.
 
 
 
22
EX-23.1 4 ex23-1.htm EXHIBIT 23.1 ex23-1.htm
EXHIBIT 23.1

 
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
 

Our report on our audits of the balance sheets of Tamir Biotechnology, Inc. as of July 31, 2010 and 2009 for the years then ended and on the statements of operations, stockholders' equity (deficiency) and cash flows and for the period from August 24, 1981 (date of inception) to July 31, 2010, included in this annual report on Form 10-K for the year ended July 31, 2010, dated October 29, 2010 expressed an unqualified opinion on those financial statements and included an explanatory paragraph regarding the Company’s ability to continue as a going concern.  We consent to the incorporation by reference of our report in the Registration Statements on Form S-8 (SEC File Nos. 33-81308, 333-110074 and 333-112866), and on Form S-3 (SEC File No. 333-112865 and 333-136678) previously filed by the Company with th e Securities and Exchange Commission pursuant to the Securities Act of 1933.

 

/s/ J.H. Cohn LLP


Roseland, New Jersey
October 29, 2010
EX-23.2 5 ex23-2.htm EXHIBIT 23.2 ex23-2.htm
EXHIBIT 23.2

 
Consent of Independent Registered Public Accounting Firm


 
The Board of Directors
Tamir Biotechnology, Inc.:

We consent to the incorporation by reference in the registration statements (No. 333-166437) on Form S-1, (Nos. 333-112865 and 333-136678) on Form S-3, and (Nos. 33-81308, 333-110074 and 333-112866) on Form S-8 of Tamir Biotechnology, Inc. (formerly known as Alfacell Corporation) of our report dated November 4, 2002, with respect to the related statements of operations, stockholders' equity (deficiency), and cash flows of Tamir Biotechnology, Inc. for the period from August 24, 1981 (date of inception) to July 31, 2002, which report appears in the July 31, 2010 annual report on Form 10-K of Tamir Biotechnology, Inc. Our report dated November 4, 2002, as it relates to the financial statements for the period from August 24, 1981 (date of inception) to July 31, 2002, is based on the report of other auditors who have cea sed operations as to the amounts included therein for the period from August 24, 1981 (date of inception) to July 31, 1992.
 
Our report dated November 4, 2002 contains an explanatory paragraph that states that the Company has suffered recurring losses from operations, has a working capital deficit and has limited liquid resources which raise substantial doubt about its ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of that uncertainty.
 
 
 
/s/ KPMG LLP
 
 
Short Hills, New Jersey
October 29, 2010
EX-31.1 6 ex31-1.htm EXHIBIT 31.1 ex31-1.htm
EXHIBIT 31.1
 
CERTIFICATION PURSUANT TO RULE 13A-14(A) AS ADOPTED
PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
 
I, Charles Muniz, certify that:
 
 
1.
I have reviewed this annual report on Form 10-K of Tamir Biotechnology, Inc.;
 
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.
I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:
 
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5.
I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
 
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.


October 29, 2010
     
  /s/ CHARLES MUNIZ  
 
Charles Muniz
 
 
Chief Executive Officer (Principal Executive Officer of Tamir Biotechnology, Inc.)
 
EX-31.2 7 ex31-2.htm EXHIBIT 31.2 ex31-2.htm
EXHIBIT 31.2

CERTIFICATION PURSUANT TO RULE 13A-14(A) AS ADOPTED
PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
 
I, Charles Muniz, certify that:
 
 
1.
I have reviewed this annual report on Form 10-K of Tamir Biotechnology, Inc.;
 
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.
I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:
 
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5.
I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
 
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 
October 29, 2010
     
  /s/ CHARLES MUNIZ  
 
Charles Muniz
 
 
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer of Tamir Biotechnology, Inc.)
 
EX-32.1 8 ex32-1.htm EXHIBIT 32.1 ex32-1.htm
EXHIBIT 32.1
 
CERTIFICATION PURSUANT TO
18 U.S.C. §1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
 
In connection with the annual report of Tamir Biotechnology, Inc. (the “Company”) on Form 10-K for the fiscal year ended July 31, 2010 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Charles Muniz, Chief Executive Officer and Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
 
 
1.
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
 
 
2.
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 

 
October 29, 2010
 

  /s/ CHARLES MUNIZ  
  Charles Muniz  
 
Chief Executive Officer and Chief Financial Officer (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer of Tamir Biotechnology, Inc.)
 

 

A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to Tamir Biotechnology, Inc. and will be furnished to the Securities and Exchange Commission or its staff upon request.
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